Reported Reactions

Devices › Automated insulin dosing device system, single hormonal control

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

Pump Mmt-1884xc 780g Us Mg Clin: medical device reports filed with FDA

362 reports name it, 2021–2025. Manufacturer given most often on reports: Medtronic Puerto Rico Operations. Product code OZP.

362
device reports naming the brand
0% of all MAUDE reports · about 75 a year
0
reports, 12 months to August 2026
15 in the 12 months before
65.7%
classified as malfunction
85.6% across the product code
0%
classified as death, as reported
0 reports · not verified by FDA

FDA's MAUDE database holds 362 reports that name the brand "Pump Mmt-1884xc 780g Us Mg Clin" (automated insulin dosing device system single hormonal control), received between September 2021 and June 2025; the manufacturer given most often on reports is Medtronic Puerto Rico Operations. Spellings of one product vary from report to report.

0 reports arrived in the 12 months to August 2026, against 15 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 (65.7%) and injury (34.3%); 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 obstruction of flow (10.2%), power problem (9.7%) and insufficient flow or under infusion (8.6%). The patient problems coded most often are hyperglycemia, elevated ketones/ diabetic ketoacidosis and hypoglycemia. 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

01530Sep 2021: 5Oct 2021: 3Nov 2021: 1Dec 2021: 12022Jan 2022: 1Feb 2022: 5Mar 2022: 5Apr 2022: 10May 2022: 15Jun 2022: 2Jul 2022: 5Aug 2022: 0Sep 2022: 9Oct 2022: 3Nov 2022: 9Dec 2022: 62023Jan 2023: 23Feb 2023: 8Mar 2023: 8Apr 2023: 19May 2023: 15Jun 2023: 9Jul 2023: 26Aug 2023: 30Sep 2023: 25Oct 2023: 18Nov 2023: 20Dec 2023: 112024Jan 2024: 15Feb 2024: 9Mar 2024: 3Apr 2024: 3May 2024: 3Jun 2024: 7Jul 2024: 9Aug 2024: 6Sep 2024: 0Oct 2024: 0Nov 2024: 0Dec 2024: 02025Jan 2025: 0Feb 2025: 0Mar 2025: 1Apr 2025: 5May 2025: 5Jun 2025: 4Jul 2025: 0Aug 2025: 0Sep 2025: 0Oct 2025: 0Nov 2025: 0Dec 2025: 02026Jan 2026: 0Feb 2026: 0Mar 2026: 0Apr 2026: 0May 2026: 0Jun 2026: 0Jul 2026: 0Aug 2026: 0

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

01062122021: 1020212022: 7020222023: 21220232024: 5520242025: 152025

Event type and report source

Event type, as classified on the report

Death0%0
Injury34.3%124
Malfunction65.7%238
Other0%0
Not given0%0

Who filed the report

Manufacturer report100%362
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
Obstruction of flow3710.2%11.7%
Power problem359.7%15.8%
Insufficient flow or under infusion318.6%2.5%
Device alarm system267.2%2%
Breakthe device broke246.6%16.1%
No display/image236.4%7.1%
Battery problema problem with the battery185%5.2%
Moisture or humidity problem164.4%3.9%
Wireless communication problema wireless connection problem164.4%5.2%
Mechanical problema mechanical problem102.8%5.3%
Unintended movement102.8%0.6%
Circuit failure92.5%2.2%
Computer software problema software problem82.2%2%
Unexpected therapeutic results82.2%1.8%
Communication or transmission problemthe device could not communicate or transmit51.4%2.3%
Insufficient device problem information30.8%1.4%
Device difficult to program or calibrate20.6%2.7%
Display or visual feedback problem20.6%2.2%
Electrical /electronic property probleman electrical or electronic problem20.6%1%
Excess flow or over-infusion20.6%1.1%

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 sugar18751.7%
Elevated ketones/ diabetic ketoacidosis4913.5%
Hypoglycemialow blood sugar205.5%
Vomitingbeing sick174.7%
Nauseafeeling sick92.5%
Malaisegeneral feeling of being unwell71.9%
Abdominal painstomach or belly pain61.7%
Headachehead pain30.8%
Dizzinesslight-headedness or unsteadiness20.6%
Erythemaskin redness20.6%
Fatiguetiredness20.6%
Loss of consciousnesspassing out20.6%
Skin inflammation/ irritation20.6%
Blurred vision10.3%
Discomfortdiscomfort10.3%

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

In context

MeasurePump Mmt-1884xc 780g Us Mg ClinProduct code OZPAll MAUDE reports
Reports362893,21526,136,888
Share of that pool—0%0%
Classified as death, per 1,000 reports019
Classified as injury34.3%14.3%36.2%
Classified as malfunction65.7%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-1884xc 780g Us Mg Clin reports

How many FDA reports name Pump Mmt-1884xc 780g Us Mg Clin?

362 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 0 in the latest 12 months.

What kinds of events are reported?

malfunction (65.7%) and injury (34.3%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.

What device problems are coded?

obstruction of flow (10.2%), power problem (9.7%), insufficient flow or under infusion (8.6%), device alarm system (7.2%) and break (6.6%). 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-1884xc 780g Us Mg Clin 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.