Reported Reactions

Devices › Pump, infusion, insulin, to be used with invasive glucose sensor

Device brand name · Pump infusion insulin to be used with invasive glucose sensor

MiniMed 720G OUS BLE Connect 3.0 mmol/L: medical device reports filed with FDA

1,092 reports name it, 2022–2026. Manufacturer given most often on reports: Medtronic Puerto Rico Operations. Product code OYC.

1,092
device reports naming the brand
0% of all MAUDE reports · about 268 a year
560
reports, 12 months to August 2026
346 in the 12 months before
99.7%
classified as malfunction
85.5% across the product code
0%
classified as death, as reported
0 reports · not verified by FDA

1,092 medical device reports received by FDA name the brand "MiniMed 720G OUS BLE Connect 3.0 mmol/L" (pump infusion insulin to be used with invasive glucose sensor); the manufacturer given most often on reports is Medtronic Puerto Rico Operations; received from June 2022 to August 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.

560 reports arrived in the 12 months to August 2026, up 62% from 346 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 (99.7%) and injury (0.3%); across all pump, infusion, insulin, to be used with invasive glucose sensor reports (product code OYC) death is recorded in 0.3% and malfunction in 85.5%. Event type is the reporter's classification of the report, not a verified outcome.

The device problems coded most often are power problem (43.8%), no display/image (13.8%) and battery problem (8%). The patient problems coded most often are hyperglycemia, hypoglycemia and appropriate clinical signs, symptoms and conditions term/code not available. 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

04080Sep 2021: 0Oct 2021: 0Nov 2021: 0Dec 2021: 02022Jan 2022: 0Feb 2022: 0Mar 2022: 0Apr 2022: 0May 2022: 0Jun 2022: 1Jul 2022: 3Aug 2022: 0Sep 2022: 0Oct 2022: 1Nov 2022: 3Dec 2022: 42023Jan 2023: 1Feb 2023: 2Mar 2023: 1Apr 2023: 3May 2023: 1Jun 2023: 4Jul 2023: 5Aug 2023: 7Sep 2023: 5Oct 2023: 9Nov 2023: 12Dec 2023: 142024Jan 2024: 11Feb 2024: 12Mar 2024: 9Apr 2024: 12May 2024: 15Jun 2024: 13Jul 2024: 13Aug 2024: 25Sep 2024: 30Oct 2024: 14Nov 2024: 15Dec 2024: 352025Jan 2025: 21Feb 2025: 15Mar 2025: 17Apr 2025: 31May 2025: 27Jun 2025: 46Jul 2025: 51Aug 2025: 44Sep 2025: 80Oct 2025: 34Nov 2025: 19Dec 2025: 382026Jan 2026: 29Feb 2026: 49Mar 2026: 37Apr 2026: 54May 2026: 44Jun 2026: 62Jul 2026: 64Aug 2026: 50

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

02124232022: 1220222023: 6420232024: 20420242025: 42320252026: 3892026

Event type and report source

Event type, as classified on the report

Death0%0
Injury0.3%3
Malfunction99.7%1,089
Other0%0
Not given0%0

Who filed the report

Manufacturer report100%1,092
Voluntary report0%0
User facility report0%0
Distributor report0%0
Not given0%0

Grey bar: all 891,173 reports carrying product code OYC. 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 problem47843.8%4.9%
No display/image15113.8%5%
Battery problema problem with the battery878%3.1%
Breakthe device broke797.2%10.1%
Mechanical problema mechanical problem746.8%3.7%
Key or button unresponsive/not working544.9%0.3%
Circuit failure514.7%1%
Obstruction of flow464.2%3%
Display or visual feedback problem413.8%0.9%
Material integrity problema problem with the device material403.7%2.7%
Electrical /electronic property probleman electrical or electronic problem211.9%0.6%
Fracturea broken bone171.6%0.2%
Insufficient device problem information171.6%2.1%
Mechanical jam121.1%0.1%
Failure of device to self-test100.9%0.3%
Unintended movement70.6%0.1%
Moisture or humidity problem60.5%1.7%
Computer software problema software problem50.5%0.4%
Device difficult to program or calibrate40.4%2.8%
Communication or transmission problemthe device could not communicate or transmit20.2%0.6%

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 sugar121.1%
Hypoglycemialow blood sugar111%
Appropriate clinical signs, symptoms and conditions term/code not available20.2%
Elevated ketones/ diabetic ketoacidosis10.1%
Hemorrhage/blood loss/bleeding10.1%

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

In context

MeasureMiniMed 720G OUS BLE Connect 3.0 mmol/LProduct code OYCAll MAUDE reports
Reports1,092891,17326,136,888
Share of that pool—0.1%0%
Classified as death, per 1,000 reports039
Classified as injury0.3%14.2%36.2%
Classified as malfunction99.7%85.5%62.3%
Filed by the manufacturer100%100%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 OYC

BrandReportsLatest 12 monthsClassified as death
Paradigm Real-Time Revel Insulin Infusion Pump178,69100.6%
Paradigm Real-Time Insulin Infusion Pump126,28200.3%
640G Insulin Pump MMT-1712K119,5471,5980.1%
640G Insulin Pump MMT-1711K76,6091510.1%
Animas Vibe88,70300%
T Slim G5 System49,78300%
t:slim G4 system39,215200%
Pump Mmt-1712kl 640g V4 10 Bk Sf Mg21,5319520%
640g Insulin Pump16,91100%
Paradigm REAL-Time REVEL Insulin Infusion Pump MMT-723LNAS12,936410.8%
t:slim X2 Insulin Pump31,159860%
Pump Mmt-1711kl 640g V4 10 Bk Sf Mm11,1571680%
Paradigm REAL-Time Insulin Infusion Pump MMT-754WWS10,4656610%
Paradigm Real-Time Revel Insulin Infusion Pump Mmt-723nas8,540490.8%
640g Insulin Pump Mmt-1712b5,62910%

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 MiniMed 720G OUS BLE Connect 3.0 mmol/L reports

How many FDA reports name MiniMed 720G OUS BLE Connect 3.0 mmol/L?

1,092 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 560 in the latest 12 months.

What kinds of events are reported?

malfunction (99.7%) and injury (0.3%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.

What device problems are coded?

power problem (43.8%), no display/image (13.8%), battery problem (8%), break (7.2%) and mechanical problem (6.8%). 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 MiniMed 720G OUS BLE Connect 3.0 mmol/L 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.