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 700 China BLE Connect 3.0 mmol/L: medical device reports filed with FDA

2,744 reports name it, 2022–2026. Manufacturer given most often on reports: Medtronic-Chengdu. Product code OYC.

2,744
device reports naming the brand
0% of all MAUDE reports · about 634 a year
1,427
reports, 12 months to August 2026
916 in the 12 months before
99.5%
classified as malfunction
85.5% across the product code
0%
classified as death, as reported
1 reports · not verified by FDA

FDA's MAUDE database holds 2,744 reports that name the brand "MiniMed 700 China BLE Connect 3.0 mmol/L" (pump infusion insulin to be used with invasive glucose sensor), received between March 2022 and August 2026; the manufacturer given most often on reports is Medtronic-Chengdu. Spellings of one product vary from report to report.

1,427 reports arrived in the 12 months to August 2026, up 56% from 916 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 (99.5%) and injury (0.5%); 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 obstruction of flow (50.5%), break (8.1%) and power problem (8.1%). 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

084168Sep 2021: 0Oct 2021: 0Nov 2021: 0Dec 2021: 02022Jan 2022: 0Feb 2022: 0Mar 2022: 1Apr 2022: 0May 2022: 0Jun 2022: 0Jul 2022: 1Aug 2022: 1Sep 2022: 5Oct 2022: 1Nov 2022: 3Dec 2022: 82023Jan 2023: 5Feb 2023: 4Mar 2023: 7Apr 2023: 2May 2023: 3Jun 2023: 7Jul 2023: 15Aug 2023: 6Sep 2023: 11Oct 2023: 13Nov 2023: 16Dec 2023: 152024Jan 2024: 21Feb 2024: 20Mar 2024: 20Apr 2024: 31May 2024: 62Jun 2024: 24Jul 2024: 52Aug 2024: 47Sep 2024: 64Oct 2024: 59Nov 2024: 60Dec 2024: 942025Jan 2025: 103Feb 2025: 35Mar 2025: 60Apr 2025: 76May 2025: 62Jun 2025: 79Jul 2025: 123Aug 2025: 101Sep 2025: 137Oct 2025: 101Nov 2025: 81Dec 2025: 1482026Jan 2026: 116Feb 2026: 140Mar 2026: 100Apr 2026: 119May 2026: 93Jun 2026: 119Jul 2026: 168Aug 2026: 105

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

05531,1062022: 2020222023: 10420232024: 55420242025: 1,10620252026: 9602026

Event type and report source

Event type, as classified on the report

Death0%1
Injury0.5%14
Malfunction99.5%2,729
Other0%0
Not given0%0

Who filed the report

Manufacturer report100%2,744
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
Obstruction of flow1,38550.5%3%
Breakthe device broke2238.1%10.1%
Power problem2238.1%4.9%
Battery problema problem with the battery2057.5%3.1%
Fracturea broken bone1154.2%0.2%
No visual prompts/feedback1083.9%0%
Material integrity problema problem with the device material933.4%2.7%
Display or visual feedback problem873.2%0.9%
Circuit failure712.6%1%
Mechanical problema mechanical problem712.6%3.7%
No display/image582.1%5%
Key or button unresponsive/not working542%0.3%
Unintended movement542%0.1%
Insufficient flow or under infusion311.1%0.7%
Visual prompts will not clear240.9%0.7%
Electrical /electronic property probleman electrical or electronic problem230.8%0.6%
Failure of device to self-test210.8%0.3%
Device alarm system200.7%2.4%
Insufficient device problem information150.5%2.1%
Priming problem150.5%0.4%

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 sugar1535.6%
Hypoglycemialow blood sugar200.7%
Elevated ketones/ diabetic ketoacidosis50.2%
Coma10%
Dizzinesslight-headedness or unsteadiness10%

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

In context

MeasureMiniMed 700 China BLE Connect 3.0 mmol/LProduct code OYCAll MAUDE reports
Reports2,744891,17326,136,888
Share of that pool—0.3%0%
Classified as death, per 1,000 reports039
Classified as injury0.5%14.2%36.2%
Classified as malfunction99.5%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 700 China BLE Connect 3.0 mmol/L reports

How many FDA reports name MiniMed 700 China BLE Connect 3.0 mmol/L?

2,744 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 1,427 in the latest 12 months.

What kinds of events are reported?

malfunction (99.5%) and injury (0.5%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.

What device problems are coded?

obstruction of flow (50.5%), break (8.1%), power problem (8.1%), battery problem (7.5%) and fracture (4.2%). 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 700 China 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.