Reported Reactions

Devices › Automated insulin dosing device system, single hormonal control

Device brand name · Automated insulin dosing device system single hormonal control

Pump Mmt-1885l Mm780g Ble Mmol: medical device reports filed with FDA

3,080 reports name it, 2021–2026. Manufacturer given most often on reports: Medtronic Puerto Rico Operations. Product code OZP.

3,080
device reports naming the brand
0% of all MAUDE reports · about 627 a year
167
reports, 12 months to August 2026
491 in the 12 months before
98.8%
classified as malfunction
85.6% across the product code
0%
classified as death, as reported
0 reports · not verified by FDA

3,080 medical device reports received by FDA name the brand "Pump Mmt-1885l Mm780g Ble Mmol" (automated insulin dosing device system single hormonal control); the manufacturer given most often on reports is Medtronic Puerto Rico Operations; received from August 2021 to August 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.

167 reports arrived in the 12 months to August 2026, down 66% from 491 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 (98.8%) and injury (1.2%); across all automated insulin dosing device system, single hormonal control reports (product code OZP) death is recorded in 0.1% and malfunction in 85.6%. Event type is the reporter's classification of the report, not a verified outcome.

The device problems coded most often are power problem (30.2%), break (25.2%) and material integrity problem (13.1%). The patient problems coded most often are hyperglycemia, hypoglycemia and elevated ketones/ diabetic ketoacidosis. 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."

Reports by month, five years

069138Sep 2021: 5Oct 2021: 7Nov 2021: 6Dec 2021: 162022Jan 2022: 7Feb 2022: 14Mar 2022: 46Apr 2022: 20May 2022: 43Jun 2022: 41Jul 2022: 116Aug 2022: 59Sep 2022: 119Oct 2022: 46Nov 2022: 71Dec 2022: 982023Jan 2023: 138Feb 2023: 76Mar 2023: 92Apr 2023: 84May 2023: 69Jun 2023: 95Jul 2023: 119Aug 2023: 124Sep 2023: 71Oct 2023: 109Nov 2023: 93Dec 2023: 732024Jan 2024: 83Feb 2024: 62Mar 2024: 71Apr 2024: 64May 2024: 100Jun 2024: 32Jul 2024: 96Aug 2024: 54Sep 2024: 65Oct 2024: 50Nov 2024: 40Dec 2024: 622025Jan 2025: 32Feb 2025: 24Mar 2025: 27Apr 2025: 52May 2025: 37Jun 2025: 32Jul 2025: 37Aug 2025: 33Sep 2025: 46Oct 2025: 29Nov 2025: 20Dec 2025: 182026Jan 2026: 11Feb 2026: 5Mar 2026: 8Apr 2026: 6May 2026: 4Jun 2026: 4Jul 2026: 11Aug 2026: 5

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

By year received

05721,1432021: 3720212022: 68020222023: 1,14320232024: 77920242025: 38720252026: 542026

Event type and report source

Event type, as classified on the report

Death0%0
Injury1.2%36
Malfunction98.8%3,044
Other0%0
Not given0%0

Who filed the report

Manufacturer report100%3,080
Voluntary report0%0
User facility report0%0
Distributor report0%0
Not given0%0

Grey bar: all 893,215 reports carrying product code OZP. Event type is the filer's classification and is not verified by FDA.

Device problems coded

Device problem (FDA code)ReportsShareShare across product code
Power problem93130.2%15.8%
Breakthe device broke77725.2%16.1%
Material integrity problema problem with the device material40513.1%7.2%
Mechanical problema mechanical problem2618.5%5.3%
No display/image2427.9%7.1%
Moisture or humidity problem2267.3%3.9%
Insufficient device problem information1645.3%1.4%
Computer software problema software problem1545%2%
Obstruction of flow1244%11.7%
Circuit failure1153.7%2.2%
Battery problema problem with the battery802.6%5.2%
Key or button unresponsive/not working792.6%3.3%
Insufficient flow or under infusion772.5%2.5%
Device difficult to program or calibrate752.4%2.7%
Display or visual feedback problem742.4%2.2%
Visual prompts will not clear581.9%0.6%
Electrical /electronic property probleman electrical or electronic problem451.5%1%
Fracturea broken bone441.4%1.4%
Unintended movement411.3%0.6%
Device alarm system371.2%2%

FDA's device problem codes as entered on the report; one report can carry several. Generic codes such as "no apparent adverse event" are left out.

Patient problems coded

Patient problem (FDA code)ReportsShare
Hyperglycemiahigh blood sugar1374.4%
Hypoglycemialow blood sugar441.4%
Elevated ketones/ diabetic ketoacidosis70.2%
Fatiguetiredness60.2%
Nauseafeeling sick60.2%
Malaisegeneral feeling of being unwell40.1%
Vomitingbeing sick40.1%
Confusion/ disorientation30.1%
Polydipsia30.1%
Abdominal painstomach or belly pain20.1%
Dyspneashortness of breath20.1%
Headachehead pain20.1%
Dehydrationdehydration10%
Diaphoresis10%
Epistaxisnosebleed10%

Patient problem codes are present mainly in reports filed since 2019 and are often blank.

In context

MeasurePump Mmt-1885l Mm780g Ble MmolProduct code OZPAll MAUDE reports
Reports3,080893,21526,136,888
Share of that pool—0.3%0%
Classified as death, per 1,000 reports019
Classified as injury1.2%14.3%36.2%
Classified as malfunction98.8%85.6%62.3%
Filed by the manufacturer100%99.9%94.9%

Shares are of reports, not 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."

Other brands with product code OZP

BrandReportsLatest 12 monthsClassified as death
Pump MMT-1780KPK 670G Pathway Black MG224,5568350.2%
MiniMed 780G US System BLE Connect 3.0 mg/dL112,81757,1400.1%
MiniMed 770G US System BLE Connect 3.0 mg/dL84,6854,8380.2%
Pump 1886 780G OUS BLE Pump mg/dL84,25936,8830%
670G Insulin Pump MMT-1780KL78,2301,1210.2%
MiniMed 780G OUS System BLE Connect 3.0 mmol/L66,71819,1940%
PUMP MMT-1884L MM780G BLE 3.0 mg/ml34,8469,7030.1%
Pump Mmt-1880l Mm770g Ble Mg24,0453,1480.2%
Pump Mmt-1782k 670g V4 11 Mm23,5871370.1%
Pump Mmt-1781k 670g V4 11 Mg17,0816170%
Xmtr Mmt-7811xww Gst3c Ous16,4141110%
MiniMed 780G OUS System BLE Connect 3.0 mg/dL14,4583400%
Xmtr MMT-7811NA GST3C Lockout17,012650%
Guardian Link 3 US11,3102290%
Pump Mmt-1780k 670g 3ml Black9,34590.2%

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." FDA also states that "common products may have a higher number of adverse events due to the higher total number of people using the product."

Questions about Pump Mmt-1885l Mm780g Ble Mmol reports

How many FDA reports name Pump Mmt-1885l Mm780g Ble Mmol?

3,080 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 167 in the latest 12 months.

What kinds of events are reported?

malfunction (98.8%) and injury (1.2%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.

What device problems are coded?

power problem (30.2%), break (25.2%), material integrity problem (13.1%), mechanical problem (8.5%) and no display/image (7.9%). These are FDA's device problem codes as entered on the report.

Who files these reports?

manufacturer reports (100%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.

Do these reports show that Pump Mmt-1885l Mm780g Ble Mmol was at fault?

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." FDA adds that "a causal relationship cannot be established between product and reactions listed in a report."

How do I report a problem with a medical device?

Through FDA MedWatch (Form FDA 3500 for health professionals and consumers), or to the manufacturer. See the guide on how to report.

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. A report counts here when any device it lists carries this brand name after punctuation and capitalisation are normalised. 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.