Automated insulin dosing device system, single hormonal control: medical device reports filed with FDA

893,215 reports carry this product code, 2015–2026; 30 brands with a page.

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.

893,215
reports with this product code: 3.4% of all MAUDE reports; 136,899
reports, 12 months to August 2026: 142,044 in the 12 months before; 85.6%
classified as malfunction: 62.3% across all reports; 0.1%
classified as death, as reported: 0.9% across all reports

Product code OZP is FDA's classification for "Automated insulin dosing device system, single hormonal control" (unknown panel), a class 3 device. 893,215 medical device reports carry this product code, 3.4% of the MAUDE database, from July 2015 to August 2026.

136,899 reports arrived in the 12 months to August 2026, close to the 142,044 of 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 (85.6%), injury (14.3%) and death (0.1%). 30 brand names with a page on this site carry this code; the brands table is 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."

Brands with this product code

Brand	Reports	Latest 12 months	Classified as death	Classified as malfunction
Pump MMT-1780KPK 670G Pathway Black MG	224,548	835	0.2%	78.8%
MiniMed 780G US System BLE Connect 3.0 mg/dL	97,633	57,140	0.1%	75.5%
MiniMed 770G US System BLE Connect 3.0 mg/dL	84,682	4,838	0.2%	83.4%
Pump 1886 780G OUS BLE Pump mg/dL	84,258	36,883	0%	99.1%
670G Insulin Pump MMT-1780KL	78,229	1,121	0.2%	81.8%
MiniMed 780G OUS System BLE Connect 3.0 mmol/L	66,718	19,194	0%	99%
PUMP MMT-1884L MM780G BLE 3.0 mg/ml	33,291	9,703	0.1%	81.1%
Pump Mmt-1880l Mm770g Ble Mg	24,045	3,148	0.2%	83.5%
Pump Mmt-1782k 670g V4 11 Mm	23,587	137	0.1%	87.8%
Pump Mmt-1781k 670g V4 11 Mg	17,081	617	0%	89.8%
Xmtr Mmt-7811xww Gst3c Ous	16,082	111	0%	99.9%
MiniMed 780G OUS System BLE Connect 3.0 mg/dL	14,458	340	0%	98.3%
Xmtr MMT-7811NA GST3C Lockout	11,464	65	0%	99.5%
Guardian Link 3 US	10,271	229	0%	99.3%
Pump Mmt-1780k 670g 3ml Black	9,345	9	0.2%	73.3%
Unknown NGP	9,022	3,982	0.8%	72.6%
Sensor Mmt-7020a Enlite3 5pk Us	8,792	199	0.1%	79.4%
Sensor Mmt-7040a Guardian4 5pk Us	8,154	2,531	0%	82.4%
MiniMed 770G OUS System BLE Connect 3.0 mmol/L	7,557	500	0.1%	93.2%
Sensor Mmt-7040c1 Guardian4 5pk Ous 1	7,280	2,007	0%	97.9%
Pump Mmt-1782kl 670g Mm Rpl	5,066	44	0%	90.3%
MiniMed 770G OUS System BLE Connect 3.0 mg/dL	4,461	594	0.1%	96.7%
Pump Mmt-1781kl 670g Mg Rpl	4,442	47	0%	90.8%
Guardian Link 3 OUS	4,163	733	0%	99.8%
Sensor Mmt-7020c1 Gs3 5pk 9l Ous1	3,910	455	0%	97.9%
Pump Mmt-1885l Mm780g Ble Mmol	3,080	167	0%	98.8%
Guardian sensor 3	2,887	434	0%	91.6%
Sensor Mmt-7040d1 Guardian4 1pk Ous 1	2,389	1,110	0%	98.2%
Sensor Mmt-7040c9 En	2,181	673	0%	98.6%
Sensor Mmt-7040d2 Guardian4 1pk Ous 2	1,857	886	0%	98.6%

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."

Manufacturers named

Manufacturer (as written on reports)	Reports	Share
Medtronic Puerto Rico Operations	810,160	90.7%
Medtronic Minimed	83,481	9.3%
Ascensia Diabetes Care US	9	0%
Roche Diabetes Care	7	0%
Medtronic-Chengdu	4	0%
Medtronic Puerto Rico Operations Juncos	2	0%
Companion Medical	1	0%
Dexcom	1	0%

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 and report source

Event type

Death0.1%1,258

Injury14.3%127,745

Malfunction85.6%764,202

Other0%8

Not given0%2

Who filed

Manufacturer report99.9%892,644

Voluntary report0.1%571

User facility report0%0

Distributor report0%0

Not given0%0

Grey bar: all 26,136,888 MAUDE reports.

Device problems coded

Device problem (FDA code)	Reports	Share
Breakthe device broke	144,194	16.1%
Power problem	141,505	15.8%
Obstruction of flow	104,269	11.7%
Material integrity problema problem with the device material	64,147	7.2%
No display/image	63,488	7.1%
Patient device interaction problem	62,687	7%
Mechanical problema mechanical problem	47,393	5.3%
Battery problema problem with the battery	46,785	5.2%
Wireless communication problema wireless connection problem	46,231	5.2%
Incorrect, inadequate or imprecise result or readings	36,427	4.1%
Moisture or humidity problem	34,633	3.9%
Key or button unresponsive/not working	29,424	3.3%
Device difficult to program or calibrate	24,268	2.7%
Insufficient flow or under infusion	22,203	2.5%
Communication or transmission problemthe device could not communicate or transmit	20,754	2.3%
Connection problema connection problem	20,699	2.3%
Circuit failure	19,409	2.2%
Display or visual feedback problem	19,313	2.2%
Device alarm system	17,748	2%
Computer software problema software problem	17,617	2%

Questions about automated insulin dosing device system, single hormonal control reports

What is product code OZP?

FDA's classification code for "Automated insulin dosing device system, single hormonal control", class 3, reviewed by the unknown panel. Every device report carries the product code of the device involved.

How many reports carry this code?

893,215 reports through August 2026, 136,899 of them in the latest 12 months.

Which brands appear most often?

Pump MMT-1780KPK 670G Pathway Black MG (224,548), MiniMed 780G US System BLE Connect 3.0 mg/dL (97,633), MiniMed 770G US System BLE Connect 3.0 mg/dL (84,682), Pump 1886 780G OUS BLE Pump mg/dL (84,258) and 670G Insulin Pump MMT-1780KL (78,229). Widely used products collect more reports because more people use them.

Can the brands table be used to rank the devices?

No. 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 differ in how many are in use, how long they have been sold and how reports are collected.

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. 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.