Reported Reactions

Devices › Automated insulin dosing device system, single hormonal control

Device brand name · Artificial pancreas device system single hormonal control

Pump Mmt-1782kl 670g Mm Rpl: medical device reports filed with FDA

5,066 reports name it, 2020–2026. Manufacturer given most often on reports: Medtronic Puerto Rico Operations. Product code OZP.

5,066
device reports naming the brand
0% of all MAUDE reports · about 822 a year
44
reports, 12 months to August 2026
109 in the 12 months before
90.3%
classified as malfunction
85.6% across the product code
0%
classified as death, as reported
1 reports · not verified by FDA

FDA's MAUDE database holds 5,066 reports that name the brand "Pump Mmt-1782kl 670g Mm Rpl" (artificial pancreas device system single hormonal control), received between May 2020 and August 2026; the manufacturer given most often on reports is Medtronic Puerto Rico Operations. Spellings of one product vary from report to report.

44 reports arrived in the 12 months to August 2026, down 60% from 109 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 (90.3%) and injury (9.6%); 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 (30.7%), break (22.5%) and material integrity problem (13.3%). 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

0209417Sep 2021: 113Oct 2021: 66Nov 2021: 61Dec 2021: 1372022Jan 2022: 104Feb 2022: 115Mar 2022: 417Apr 2022: 92May 2022: 121Jun 2022: 160Jul 2022: 371Aug 2022: 140Sep 2022: 319Oct 2022: 96Nov 2022: 171Dec 2022: 2312023Jan 2023: 270Feb 2023: 103Mar 2023: 137Apr 2023: 140May 2023: 85Jun 2023: 98Jul 2023: 105Aug 2023: 109Sep 2023: 56Oct 2023: 75Nov 2023: 67Dec 2023: 452024Jan 2024: 66Feb 2024: 52Mar 2024: 40Apr 2024: 29May 2024: 41Jun 2024: 19Jul 2024: 35Aug 2024: 18Sep 2024: 21Oct 2024: 15Nov 2024: 17Dec 2024: 102025Jan 2025: 5Feb 2025: 6Mar 2025: 10Apr 2025: 6May 2025: 5Jun 2025: 2Jul 2025: 7Aug 2025: 5Sep 2025: 7Oct 2025: 2Nov 2025: 2Dec 2025: 72026Jan 2026: 5Feb 2026: 4Mar 2026: 3Apr 2026: 3May 2026: 1Jun 2026: 1Jul 2026: 1Aug 2026: 8

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

01,1692,3372020: 15120202021: 83520212022: 2,33720222023: 1,29020232024: 36320242025: 6420252026: 262026

Event type and report source

Event type, as classified on the report

Death0%1
Injury9.6%488
Malfunction90.3%4,577
Other0%0
Not given0%0

Who filed the report

Manufacturer report100%5,066
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 problem1,55330.7%15.8%
Breakthe device broke1,13922.5%16.1%
Material integrity problema problem with the device material67513.3%7.2%
No display/image4258.4%7.1%
Mechanical problema mechanical problem3587.1%5.3%
Moisture or humidity problem3356.6%3.9%
Computer software problema software problem2855.6%2%
Device difficult to program or calibrate2585.1%2.7%
Obstruction of flow2494.9%11.7%
Battery problema problem with the battery1713.4%5.2%
Communication or transmission problemthe device could not communicate or transmit1563.1%2.3%
Circuit failure1162.3%2.2%
Insufficient device problem information941.9%1.4%
Insufficient flow or under infusion891.8%2.5%
Display or visual feedback problem821.6%2.2%
Unintended movement791.6%0.6%
Visual prompts will not clear781.5%0.6%
Device alarm system681.3%2%
Electrical /electronic property probleman electrical or electronic problem671.3%1%
Key or button unresponsive/not working521%3.3%

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 sugar57611.4%
Hypoglycemialow blood sugar1693.3%
Elevated ketones/ diabetic ketoacidosis300.6%
Nauseafeeling sick240.5%
Vomitingbeing sick100.2%
Loss of consciousnesspassing out70.1%
Headachehead pain60.1%
Fatiguetiredness50.1%
Polydipsia50.1%
Diaphoresis40.1%
Shaking/tremors40.1%
Abdominal painstomach or belly pain30.1%
Confusion/ disorientation30.1%
Hypoglycemic shock30.1%
Urinary frequency / polyuria30.1%

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

In context

MeasurePump Mmt-1782kl 670g Mm RplProduct code OZPAll MAUDE reports
Reports5,066893,21526,136,888
Share of that pool—0.6%0%
Classified as death, per 1,000 reports019
Classified as injury9.6%14.3%36.2%
Classified as malfunction90.3%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-1782kl 670g Mm Rpl reports

How many FDA reports name Pump Mmt-1782kl 670g Mm Rpl?

5,066 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 44 in the latest 12 months.

What kinds of events are reported?

malfunction (90.3%) and injury (9.6%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.

What device problems are coded?

power problem (30.7%), break (22.5%), material integrity problem (13.3%), no display/image (8.4%) and mechanical problem (7.1%). 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-1782kl 670g Mm Rpl 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.