Device manufacturer, as written on reports

Medtronic Minimed: medical device reports filed with FDA

442,554 reports name it as the manufacturer of the device involved, 2002–2026.

Read first · FDA's statement on these data

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. openFDA, FDA

FDA adds: "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." And: "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."

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.

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

442,554
reports naming it as manufacturer: 1.7% of all MAUDE reports; 54,842
reports, 12 months to August 2026: 62,244 in the 12 months before; 84.7%
classified as malfunction: 62.3% across all reports; 0.4%
classified as death, as reported: 0.9% across all reports

442,554 medical device reports received by FDA give Medtronic Minimed as the manufacturer of the device involved, 1.7% of the MAUDE database, from February 2002 to August 2026. Manufacturer names are as written on the report; subsidiaries and spelling variants may appear as separate names.

54,842 reports arrived in the 12 months to August 2026, down 12% from 62,244 in the 12 months before. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases. The event types recorded are malfunction (84.7%), injury (14.9%) and death (0.4%). Manufacturers are required to report events they learn of, so a large manufacturer with many products in use files many reports. FDA states that "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." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."

Brands named most often

Brand	Device type	Reports	Latest 12 months	Classified as death
Paradigm Real-Time Revel Insulin Infusion Pump	Pump, infusion, insulin, to be used with invasive glucose sensor	61,173	0	0.6%
Paradigm Real-Time Insulin Infusion Pump	Pump, infusion, insulin, to be used with invasive glucose sensor	48,973	0	0.3%
Transmitter Mmt-7841zn Gst5g Us	Sensor, glucose, invasive, non-adjunctive	42,010	14,186	0%
Transmitter Mmt-7841zw Gst5g Ous	Sensor, glucose, invasive, non-adjunctive	31,568	12,351	0%
Smartphone Android App: Pump Connect	Insulin pump secondary display	19,765	2,720	0%
Sensor Enlite	Automated insulin dosing , threshold suspend	17,734	0	0%
Xmtr MMT-7811NA GST3C Lockout	Automated insulin dosing device system, single hormonal control	16,809	65	0%
Xmtr Mmt-7811xww Gst3c Ous	Automated insulin dosing device system, single hormonal control	16,132	111	0%
Smartphone iOS App: Pump Connect	Insulin pump secondary display	14,764	1,121	0%
Guardian Link 3 US	Automated insulin dosing device system, single hormonal control	11,223	229	0%
Sensor Enlite Mmt-7008a	Automated insulin dosing , threshold suspend	7,677	13	0.3%
Guardian Link 3 OUS	Automated insulin dosing device system, single hormonal control	6,662	733	0%
Unknown NGP	Automated insulin dosing device system, single hormonal control	6,351	3,982	0.8%
Paradigm Insulin Infusion Pump	Pump, infusion, insulin	6,182	0	0.4%
Sensor Mmt-7040c1 Guardian4 5pk Ous 1	Automated insulin dosing device system, single hormonal control	5,635	2,007	0%
Sensor Mmt-7020a Enlite3 5pk Us	Automated insulin dosing device system, single hormonal control	5,462	199	0.1%
Insulin Infusion Pump	Pump, infusion, insulin, to be used with invasive glucose sensor	4,997	0	2.6%
Unknown XMTR	Sensor, glucose, invasive	4,422	2,027	0%
Carelink Personal Mmt-7333	Sensor, glucose, invasive	3,513	233	0%
Sensor Mmt-7040a Guardian4 5pk Us	Automated insulin dosing device system, single hormonal control	3,447	2,531	0%
Reservoir 3ml	Pump, infusion	2,902	0	0.8%
Sensor Mmt-5120c Instinct 780 5pk Ous 1	Sensor, glucose, invasive, non-adjunctive	2,877	1,681	0%
Sensor Mmt-5120d1 Instinct 780 1pk Ous 1	Sensor, glucose, invasive, non-adjunctive	2,717	1,753	0%
Sensor Mmt-7020c1 Gs3 5pk 9l Ous1	Automated insulin dosing device system, single hormonal control	2,520	455	0%
530g Insulin Pump	Automated insulin dosing , threshold suspend	2,245	0	0.8%
Sensor Mmt-7040d1 Guardian4 1pk Ous 1	Automated insulin dosing device system, single hormonal control	2,073	1,110	0%
Carelink Connect app iOS	Insulin pump secondary display	1,855	126	0%
Sensor Mmt-5120d2 Instinct 780 1pk Ous 2	Sensor, glucose, invasive, non-adjunctive	1,705	1,062	0%
Sensor Enlite Mmt-7008b	Automated insulin dosing , threshold suspend	1,665	3	0%
Transmitter Mmt-7841qzw Gst5g Ous Lckout	Sensor, glucose, invasive, non-adjunctive	1,632	187	0%

Brands with a page on this site, ordered by report count for navigation only. FDA states that "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." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."

Device types

Product code	Device type	Reports	Share
OYC	Pump, infusion, insulin, to be used with invasive glucose sensor	126,793	28.7%
OZP	Automated insulin dosing device system, single hormonal control	83,481	18.9%
PQF	Sensor, glucose, invasive, non-adjunctive	82,929	18.7%
MDS	Sensor, glucose, invasive	41,125	9.3%
PKU	Insulin pump secondary display	38,038	8.6%
OZO	Automated insulin dosing , threshold suspend	30,353	6.9%
LZG	Pump, infusion, insulin	21,512	4.9%
FRN	Pump, infusion	4,872	1.1%
SFI	Sensor, glucose, invasive, component of automated insulin delivery system	4,134	0.9%
FPA	Set, administration, intravascular	2,605	0.6%

Reports by month, five years

FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases.

Event type

Death0.4%1,569

Injury14.9%65,968

Malfunction84.7%374,707

Other0%22

Not given0.1%288

Grey bar: all 26,136,888 MAUDE reports. Event type is the filer's classification and is not verified by FDA.

Questions about Medtronic Minimed reports

How many FDA device reports name Medtronic Minimed as manufacturer?

442,554 reports through August 2026, 54,842 of them in the latest 12 months.

Which of its brands appear most often?

Paradigm Real-Time Revel Insulin Infusion Pump (61,173), Paradigm Real-Time Insulin Infusion Pump (48,973), Transmitter Mmt-7841zn Gst5g Us (42,010), Transmitter Mmt-7841zw Gst5g Ous (31,568) and Smartphone Android App: Pump Connect (19,765).

Which device types does it report on?

pump, infusion, insulin, to be used with invasive glucose sensor (28.7%), automated insulin dosing device system, single hormonal control (18.9%), sensor, glucose, invasive, non-adjunctive (18.7%) and sensor, glucose, invasive (9.3%).

Does a high count say something about the manufacturer?

Not by itself. Manufacturers must file a report for every event they become aware of, so report volume follows the number of devices in use. FDA states that "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." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."

Where this comes from. Counts are built from the openFDA Device Adverse Event (MAUDE) bulk export released 28 Sep 2026, which holds reports FDA received through 31 Aug 2026. Brand, generic and manufacturer names are as written on the reports; product code names come from FDA's device classification. Manufacturer names are pooled after company suffixes (Inc., LLC, GmbH and similar) are dropped; names that read as a person rather than an organisation are never published. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.

Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.