Reported Reactions

Adverse event reports that FDA received

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Medtronic Minimed medical device reports that give this manufacturer

Name type
Device manufacturer, as written on reports

What a report is

A report is not proof that the device was the cause of the event.

FDA says:

Adverse event reports submitted to FDA do not undergo extensive validation or verification. Therefore, a causal relationship cannot be established between product and reactions listed in a report. While a suspected relationship may exist, it is not medically validated and should not be the sole source of information for clinical decision making or other assumptions about the safety or efficacy of a product. Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product.

Source: openFDA, Device Adverse Event Overview, section "Responsible use of the data". The site read the page on . The data have the reports that FDA received through .

FDA also says:

Although MDRs are a valuable source of information, this passive surveillance system has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data. In addition, the incidence or prevalence of an event cannot be determined from this reporting system alone due to potential under-reporting of events and lack of information about frequency of device use.

Source: openFDA, Device Adverse Event Overview. The site read the page on .

MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices.

Source: openFDA, Manufacturer and User Facility Device Experience. The site read the page on .

Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.

Source: openFDA, Response of the drug event API (meta.disclaimer). The site read the page on .

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

Reports on file

From February 2002 to September 2026, FDA received 443,940 medical device reports that give Medtronic Minimed as the manufacturer. A manufacturer name is as written on the report, so a subsidiary or a different spelling can be a separate name.

FDA received 46,976 reports in the 12 months to September 2026 and 67,759 in the 12 months before. FDA releases MAUDE data every month. Reports can arrive months after an event, so the newest months grow in later releases.

Of the 3,444,740 device reports that FDA received in the 12 months to September 2026, 46,976 (1.4%) give Medtronic Minimed as the manufacturer. Manufacturer reports were 99.8% of the reports that name this manufacturer and 94.9% of all device reports.

The number of people who use the product is not in the data. A count is not a rate.

Why manufacturers report

FDA says:

Mandatory reporters (that is, manufacturers, device user facilities, and importers) are required to submit to the FDA certain types of reports for adverse events and product problems about medical devices.

Source: FDA Center for Devices and Radiological Health, Medical Device Reporting (MDR): How to Report Medical Device Problems. Content current as of . The site read the page on .

Data version

openFDA MAUDE release of 23 Oct 2026. Reports received through 30 Sep 2026.

Brand names

The table has the 147 brand pages with 50 or more reports that give this manufacturer. 160 brand pages have a report in all. The rows are in order of name. A brand page with fewer reports is not in the table.

FDA says:

MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices.

Source: openFDA, Manufacturer and User Facility Device Experience. The site read the page on .

Brand names in the reports that give Medtronic Minimed as the manufacturer, in order of name
Brand nameProduct codeReportsReports, 12 months to September 2026
530g Insulin PumpAutomated insulin dosing , threshold suspend2,2450
640g Insulin PumpPump, infusion, insulin, to be used with invasive glucose sensor790
Belt ClipPump, infusion, insulin, to be used with invasive glucose sensor3140
Belt Clip Pump ClearSensor, glucose, invasive1570
Carelink Connect app AndroidInsulin pump secondary display1,03584
Carelink Connect app iOSInsulin pump secondary display1,85597
Carelink Personal Mmt-7333Sensor, glucose, invasive3,523224
Carelink Pro OnlineContinuous glucose monitor retrospective data analysis software66157
Carelink Web UploaderContinuous glucose monitor retrospective data analysis software3931
Charger Mmt-7715 Minilink Ipro ReplSensor, glucose, invasive2950
Gst4c OusSensor, glucose, invasive1,5831
Guardian Android appSensor, glucose, invasive19254
Guardian iOS appSensor, glucose, invasive39751
Guardian Link 3 OUSAutomated insulin dosing device system, single hormonal control6,690654
Guardian Link 3 USAutomated insulin dosing device system, single hormonal control11,223166
Guardian sensor 3Automated insulin dosing device system, single hormonal control1,569266
Inset GuardSet, administration, intravascular67753,901
Insulin Infusion PumpPump, infusion, insulin, to be used with invasive glucose sensor4,9970
Insulin PumpPump, infusion, insulin, to be used with invasive glucose sensor1,3611
Minilink TransmitterSensor, glucose, invasive5770
Minilink Transmitter Transmitter And Sensor Mmt-7002Sensor, glucose, invasive1780
Mmt-515 Paradigm Insulin PumpPump, infusion, insulin954
MMT-712 PARADIGM Insulin PumpPump, infusion, insulin3433,815
MMT-715 PARADIGM Insulin PumpPump, infusion, insulin423119
Model Not SpecifiedPump, infusion, insulin6220
Paradigm Insulin Infusion PumpPump, infusion, insulin6,1820
Paradigm Model Mmt-715 SmokePump, infusion, insulin1430
Paradigm PolyfinSet, administration, intravascular2070
Paradigm QuickserterIntroducer, syringe needle2360
Paradigm Real-Time Insulin Infusion PumpPump, infusion, insulin, to be used with invasive glucose sensor48,9730
Paradigm Real-Time Insulin Infusion Pump Mmt-522lnasPump, infusion, insulin, to be used with invasive glucose sensor640
Paradigm Real-Time Insulin Infusion Pump Mmt-722lnabPump, infusion, insulin, to be used with invasive glucose sensor1500
Paradigm REAL-Time Insulin Infusion Pump MMT-722LNASPump, infusion, insulin, to be used with invasive glucose sensor3415
Paradigm Real-Time Insulin Infusion Pump Mmt-722nalPump, infusion, insulin, to be used with invasive glucose sensor1180
Paradigm REAL-Time Insulin Infusion Pump MMT-754LWWSPump, infusion, insulin, to be used with invasive glucose sensor5456
Paradigm Real-Time Revel Insulin Infusion PumpPump, infusion, insulin, to be used with invasive glucose sensor61,1730
Paradigm Real-Time Revel Insulin Infusion Pump Mmt-523lnasPump, infusion, insulin, to be used with invasive glucose sensor1060
Paradigm Real-Time Revel Insulin Infusion Pump Mmt-523rnabPump, infusion, insulin, to be used with invasive glucose sensor950
Paradigm Real-Time Revel Insulin Infusion Pump Mmt-523rnalPump, infusion, insulin, to be used with invasive glucose sensor850
Paradigm Real-Time Revel Insulin Infusion Pump Mmt-523rnasPump, infusion, insulin, to be used with invasive glucose sensor3590
Paradigm REAL-Time REVEL Insulin Infusion Pump MMT-723LNALPump, infusion, insulin, to be used with invasive glucose sensor1147
Paradigm REAL-Time REVEL Insulin Infusion Pump MMT-723LNASPump, infusion, insulin, to be used with invasive glucose sensor36328
Paradigm Real-Time Revel Insulin Infusion Pump Mmt-723rnabPump, infusion, insulin, to be used with invasive glucose sensor3230
Paradigm Real-Time Revel Insulin Infusion Pump Mmt-723rnahPump, infusion, insulin, to be used with invasive glucose sensor1670
Paradigm Real-Time Revel Insulin Infusion Pump Mmt-723rnalPump, infusion, insulin, to be used with invasive glucose sensor2401
Paradigm Real-Time Revel Insulin Infusion Pump Mmt-723rnapPump, infusion, insulin, to be used with invasive glucose sensor2551
Paradigm Real-Time Revel Insulin Infusion Pump Mmt-723rnasPump, infusion, insulin, to be used with invasive glucose sensor89511
Prdgm Insulin PumpPump, infusion, insulin, to be used with invasive glucose sensor4140
PumpPump, infusion, insulin, to be used with invasive glucose sensor4465
Pump Insulin 511 Na Blue LoanerPump, infusion, insulin2310
Pump Insulin 511 Na Clear LoanerPump, infusion, insulin1810
Pump Insulin 511 Na Smoke LoanerPump, infusion, insulin2350
Pump Insulin 512 Na SmokePump, infusion, insulin1470
Pump Insulin 712 Na SmokePump, infusion, insulin1970
Pump MMT-1780KPK 670G Pathway Black MGAutomated insulin dosing device system, single hormonal control50739
Pump Mmt-512lnas Prdgm Ins Sk En Us LnPump, infusion, insulin1970
Pump Mmt-515lnas Prdgm Ins V2 1 Sk EnPump, infusion, insulin1380
Pump Mmt-522lnab Prdgm Ins Bl En MlPump, infusion, insulin1510
Pump Mmt-522lnal Prdgm Ins Cl En MlPump, infusion, insulin2770
Pump Mmt-522lnap Prdgm Ins Pl En MlPump, infusion, insulin1850
Pump Mmt-522lnas Prdgm Ins Sk En MlPump, infusion, insulin3080
Pump Mmt-522nal Prdgm Ins V2 2 Cl EnPump, infusion, insulin560
Pump Mmt-522nas Prdgm Ins V2 2 Sk EnPump, infusion, insulin1230
Pump Mmt-712lnas Prdgm Ins Sk En Us LnPump, infusion, insulin2120
Pump Mmt-715lnab Prdgm Ins V2 1 Bl EnPump, infusion, insulin1400
Pump Mmt-715lnal Prdgm Ins V2 1 Cl EnPump, infusion, insulin1460
Pump Mmt-715lnap Prdgm Ins V2 1 Pl EnPump, infusion, insulin1220
Pump Mmt-715lnas Prdgm Ins V2 1 Sk EnPump, infusion, insulin3140
Pump Mmt-715nas Prdgm Ins V2 1 Sk EnPump, infusion, insulin830
Pump Mmt-722lnab Prdgm Ins Bl En MlPump, infusion, insulin2650
Pump Mmt-722lnap Prdgm Ins Pl En MlPump, infusion, insulin1850
Pump Mmt-722lnas Prdgm Ins Sk En MlPump, infusion, insulin4990
Pump Mmt-722nab Prdgm Ins V2 2 Bl EnPump, infusion, insulin790
Pump Mmt-722nal Prdgm Ins V2 2 Cl En PrPump, infusion, insulin740
Pump Mmt-722nal Prdgm Insulin Cl EnPump, infusion, insulin2820
Pump Mmt-722nap Prdgm Ins V2 2 Pl EnPump, infusion, insulin1030
Pump Mmt-722nas Prdgm Ins V2 2 Sk EnPump, infusion, insulin2500
Pump Mmt-722rnas Prdgm Ins Sk En RcPump, infusion, insulin2300
Pump Us Insulin 508 BluePump, infusion, insulin3620
Pump Us Insulin 508 CharPump, infusion, insulin5080
Pump Us Insulin 508 TealPump, infusion, insulin1750
Quick SetSet, administration, intravascular42325,012
ReservoirPump, infusion2450
Reservoir 1 8mlPump, infusion2310
Reservoir 3mlPump, infusion2,9020
Reservoir 3ML MMT-332APump, infusion4301,862
Rpl Mmt-7811w1 Xmtr Gst3c Lockout 2 2aSensor, glucose, invasive7433
Rpl Mmt-7811w2 Xmtr Gst3c Lockout 2 2aSensor, glucose, invasive1080
Rsvr Mmt-326a 10pk Prdgm 1 8ml 13lSyringe, piston7170
Rsvr Mmt-332a 10pk Prdgm 3cc 14lSyringe, piston3300
Rsvr PrdgmSyringe, piston5620
SensorSensor, glucose, invasive67948
Sensor EnliteAutomated insulin dosing , threshold suspend17,7340
Sensor Enlite Mmt-7008aAutomated insulin dosing , threshold suspend7,6774
Sensor Enlite Mmt-7008bAutomated insulin dosing , threshold suspend1,6651
Sensor Mmt-5100jc1 Simplera 5pk Ous1Sensor, glucose, invasive, non-adjunctive1,014712
Sensor Mmt-5100jd1 Simplera 1pk Ous1Sensor, glucose, invasive, non-adjunctive1,261721
Sensor Mmt-5100jd2 Simplera 1pk Ous2Sensor, glucose, invasive, non-adjunctive151218
Sensor Mmt-5100jd3 Simplera 1pk Ous3Sensor, glucose, invasive, non-adjunctive147190
Sensor Mmt-5120a Simplera Sync 5pk UsSensor, glucose, invasive, component of automated insulin delivery system710813
Sensor Mmt-5120c Instinct 780 5pk Ous 1Sensor, glucose, invasive, non-adjunctive2,9351,590
Sensor Mmt-5120d1 Instinct 780 1pk Ous 1Sensor, glucose, invasive, non-adjunctive2,7991,648
Sensor Mmt-5120d2 Instinct 780 1pk Ous 2Sensor, glucose, invasive, non-adjunctive1,741941
Sensor Mmt-5120ma Sim Sync 5pk Med UsSensor, glucose, invasive, component of automated insulin delivery system179189
Sensor Mmt-7002c 10pk Glucose Bsa 17lSensor, glucose, invasive1550
Sensor Mmt-7020a Enlite3 5pk UsAutomated insulin dosing device system, single hormonal control5,462120
Sensor MMT-7020B Enlite3 USAutomated insulin dosing device system, single hormonal control33817
Sensor Mmt-7020c1 Gs3 5pk 9l Ous1Automated insulin dosing device system, single hormonal control2,520321
Sensor Mmt-7020c2 Gs3 5pk 9l Ous1Automated insulin dosing device system, single hormonal control16435
Sensor Mmt-7020c3 Gs3 5pk 9l Ous1Automated insulin dosing device system, single hormonal control375194
Sensor Mmt-7020c4 Gs3 5pk 2l CanadaAutomated insulin dosing device system, single hormonal control15458
Sensor Mmt-7020c5 Gs3 5pk 1l AusAutomated insulin dosing device system, single hormonal control1744
Sensor MMT-7020D1 Guardian Sn3 1PK OUS1Automated insulin dosing device system, single hormonal control958271
Sensor Mmt-7020d2 Guardian Sn3 1pk Ous2Automated insulin dosing device system, single hormonal control42955
Sensor MMT-7020D3 Guardian Sn3 1PK OUS3Automated insulin dosing device system, single hormonal control27684
Sensor Mmt-7040a Guardian4 5pk UsAutomated insulin dosing device system, single hormonal control3,4621,994
Sensor Mmt-7040c1 Guardian4 5pk Ous 1Automated insulin dosing device system, single hormonal control5,6871,600
Sensor Mmt-7040c2 Guardian4 5pk Ous 2Automated insulin dosing device system, single hormonal control69446
Sensor Mmt-7040c3 Guardian4 5pk Ous 3Automated insulin dosing device system, single hormonal control123202
Sensor Mmt-7040c5 Guardian4 5pk Ous 5Automated insulin dosing device system, single hormonal control245240
Sensor Mmt-7040c9 EnAutomated insulin dosing device system, single hormonal control1,242593
Sensor Mmt-7040d1 Guardian4 1pk Ous 1Automated insulin dosing device system, single hormonal control2,100931
Sensor Mmt-7040d2 Guardian4 1pk Ous 2Automated insulin dosing device system, single hormonal control1,514788
Sensor Mmt-7040d8 Guardian4 1pk 3l Ous 8Automated insulin dosing device system, single hormonal control123198
Sensor Mmt-7040ma Gs3 5pk UsAutomated insulin dosing device system, single hormonal control552419
Sftwr Css7201 Guardian Android AppSensor, glucose, invasive9200
Sftwr Mmt-6121 Fota Android Ous/UsMedical device data system6370
Sftwr Mmt-6122 Fota Ios Ous/UsMedical device data system6270
SFTWR MMT-8401 CGM Module AndroidSensor, glucose, invasive, non-adjunctive107138
Smartphone Android App: Pump ConnectInsulin pump secondary display19,7651,596
Smartphone iOS App: Pump ConnectInsulin pump secondary display14,764758
Sof Set Mirco QrSet, administration, intravascular1540
Sof Set UltimateSet, administration, intravascular3430
Software Css7200 Grdn Ios AppSensor, glucose, invasive1,0531
Starter Kit Mmt-7821ww Gst4c OusSensor, glucose, invasive8320
Transmitter Mmt-7731 Gst3b ReplacementSensor, glucose, invasive1,1160
Transmitter Mmt-7841qzw Gst5g Ous LckoutSensor, glucose, invasive, non-adjunctive1,632161
Transmitter Mmt-7841zn Gst5g UsSensor, glucose, invasive, non-adjunctive42,19511,479
Transmitter Mmt-7841zw Gst5g OusSensor, glucose, invasive, non-adjunctive31,95711,302
Unknown Fota SftwrMedical device data system539146
Unknown NGPAutomated insulin dosing device system, single hormonal control6,3513,940
Unknown PARADIGMPump, infusion, insulin, to be used with invasive glucose sensor116153
Unknown SENSORSensor, glucose, invasive169268
Unknown XMTRSensor, glucose, invasive4,4751,940
Xmtr MMT-7811NA GST3C LockoutAutomated insulin dosing device system, single hormonal control16,80945
Xmtr Mmt-7811xww Gst3c OusAutomated insulin dosing device system, single hormonal control16,13284
Xmtr Mmt-7821lna Gst4c ReplacementSensor, glucose, invasive1,6299

Device types

The table has the 24 device types with 5 or more reports that give this manufacturer. The rows are in order of name.

FDA says:

MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices.

Source: openFDA, Manufacturer and User Facility Device Experience. The site read the page on .

Device types in the reports that give Medtronic Minimed as the manufacturer, in order of name
Device typeProduct codeReports
Accessories, pump, infusionMRZ8
Alternate controller enabled insulin infusion pumpQFG163
Automated insulin dosing , threshold suspendOZO30,353
Automated insulin dosing device system, single hormonal controlOZP83,699
Calculator, drug doseNDC293
Catheter, intravascular, therapeutic, short-term less than 30 daysFOZ5
Continuous glucose monitor retrospective data analysis softwarePHV2,070
Glucose oxidase, glucoseCGA1,024
Insulin pump secondary displayPKU38,045
Introducer, syringe needleKZH208
Medical device data systemOUG2,087
Pump, infusionFRN4,878
Pump, infusion, implanted, programmableLKK8
Pump, infusion, insulinLZG21,512
Pump, infusion, insulin, to be used with invasive glucose sensorOYC126,803
Sensor, glucose, invasiveMDS41,207
Sensor, glucose, invasive, component of automated insulin delivery systemSFI4,445
Sensor, glucose, invasive, non-adjunctivePQF83,646
Set, administration, intravascularFPA2,605
Single use only blood lancet with an integral sharps injury prevention featureFMK6
Syringe, pistonFMF1,780
System, test, blood glucose, over the counterNBW16
Tubes, vials, systems, serum separators, blood collectionJKA31
Warmer, thermal, infusion fluidLGZ28

Reports by month

Reports that give Medtronic Minimed as the manufacturer, by month, five years to September 2026
010,00020,00020222023202420252026

FDA releases MAUDE data every month. Reports can arrive months after an event, so the newest months grow in later releases.

Event type

Event type in the reports that give Medtronic Minimed as the manufacturer
Event typeReportsShareShare as a bar
Death1,5690.4%
Injury65,98814.9%
Malfunction376,07384.7%
Other22under 0.1%
Not given2880.1%

The event type is the classification that the reporter gave. FDA does not verify it.

Official pages

The site checked these addresses on . The links open in a new tab.

Cite this page

Reported Reactions. Medtronic Minimed: medical device reports that give this manufacturer. https://reportedreactions.com/manufacturer/medtronic-minimed/ Source: U.S. Food and Drug Administration, openFDA Device Adverse Event (MAUDE) files, release of . Reports received through .

Where the data come from

The counts come from the openFDA Device Adverse Event (MAUDE) bulk files, release of 23 Oct 2026. The files have the reports that FDA received through 30 Sep 2026. Brand names, generic names and manufacturer names are as written on the reports. The names of the product codes come from the device classification of FDA.

The site removes company suffixes (Inc., LLC, GmbH and similar) before it counts a manufacturer name. A name that reads as a person and not as an organisation is not published. The site does not publish a report narrative, a lot number, a detail of a patient or the identity of a reporter. The record of FDA is the authority. See how the site counts reports, the data sources and the corrections page.

Questions

Does a large count say something about the manufacturer?

Not by itself. FDA says:

MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices.

Source: openFDA, Manufacturer and User Facility Device Experience. The site read the page on .

The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices.

Source: openFDA, Manufacturer and User Facility Device Experience. The site read the page on .

What event types do the reports record?

Death (1,569), injury (65,988), malfunction (376,073) and other (22). The event type is the classification that the reporter gave. FDA does not verify it.

Why can one company have more than one page?

The manufacturer field is free text on the report. This page counts the 443,940 reports with the name Medtronic Minimed after the site removes company suffixes. A subsidiary, a plant or a different spelling is a separate name.