Reported Reactions

Devices › Alternate controller enabled insulin infusion pump

Device brand name · Alternate controller enabled infusion pump

T Slim X2 Insulin Pump With Interoperable Technology With T Connect Mobile Ap: medical device reports filed with FDA

453 reports name it, 2024–2025. Manufacturer given most often on reports: Tandem Diabetes Care. Product code QFG.

453
device reports naming the brand
0% of all MAUDE reports · about 182 a year
0
reports, 12 months to August 2026
364 in the 12 months before
81.7%
classified as malfunction
88.9% across the product code
0%
classified as death, as reported
0 reports · not verified by FDA

FDA's MAUDE database holds 453 reports that name the brand "T Slim X2 Insulin Pump With Interoperable Technology With T Connect Mobile Ap" (alternate controller enabled infusion pump), received between January 2024 and June 2025; the manufacturer given most often on reports is Tandem Diabetes Care. Spellings of one product vary from report to report.

0 reports arrived in the 12 months to August 2026, against 364 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 (81.7%) and injury (18.3%); across all alternate controller enabled insulin infusion pump reports (product code QFG) death is recorded in 0% and malfunction in 88.9%. Event type is the reporter's classification of the report, not a verified outcome.

The device problems coded most often are charging problem (25.8%), pumping stopped (18.5%) and incorrect measurement (10.2%). 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

04692Sep 2021: 0Oct 2021: 0Nov 2021: 0Dec 2021: 02022Jan 2022: 0Feb 2022: 0Mar 2022: 0Apr 2022: 0May 2022: 0Jun 2022: 0Jul 2022: 0Aug 2022: 0Sep 2022: 0Oct 2022: 0Nov 2022: 0Dec 2022: 02023Jan 2023: 0Feb 2023: 0Mar 2023: 0Apr 2023: 0May 2023: 0Jun 2023: 0Jul 2023: 0Aug 2023: 0Sep 2023: 0Oct 2023: 0Nov 2023: 0Dec 2023: 02024Jan 2024: 2Feb 2024: 1Mar 2024: 9Apr 2024: 16May 2024: 41Jun 2024: 5Jul 2024: 6Aug 2024: 9Sep 2024: 0Oct 2024: 0Nov 2024: 0Dec 2024: 252025Jan 2025: 22Feb 2025: 20Mar 2025: 84Apr 2025: 92May 2025: 83Jun 2025: 38Jul 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.

Event type and report source

Event type, as classified on the report

Death0%0
Injury18.3%83
Malfunction81.7%370
Other0%0
Not given0%0

Who filed the report

Manufacturer report100%453
Voluntary report0%0
User facility report0%0
Distributor report0%0
Not given0%0

Grey bar: all 1,297,995 reports carrying product code QFG. Event type is the filer's classification and is not verified by FDA.

Device problems coded

Device problem (FDA code)ReportsShareShare across product code
Charging problem11725.8%7.4%
Pumping stopped8418.5%27.1%
Incorrect measurementthe device measured wrongly4610.2%6.8%
Mechanical problema mechanical problem306.6%2.8%
Filling problem255.5%2.4%
Battery problema problem with the battery235.1%5.3%
Loose or intermittent connection214.6%0.7%
Obstruction of flow214.6%6.4%
Detachment of device or device componentpart of the device came off153.3%1%
Breakthe device broke92%1.1%
Leak/splashthe device leaked81.8%0.7%
Communication or transmission problemthe device could not communicate or transmit71.5%4.7%
Difficult to insertthe device was hard to insert61.3%1.2%
Failure to power up61.3%0.3%
False alarm61.3%2.4%
Fitting problem61.3%0.5%
Crackthe device cracked51.1%2%
Date/time-related software problem51.1%1.3%
Device sensing problem51.1%1.6%
No display/image20.4%0.1%

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 sugar5712.6%
Elevated ketones/ diabetic ketoacidosis194.2%
Hypoglycemialow blood sugar194.2%
Loss of consciousnesspassing out40.9%
Memory loss/impairment30.7%
Bone fracture(s)20.4%
Confusion/ disorientation10.2%
Fatiguetiredness10.2%
Myocardial infarctionheart attack10.2%
Nauseafeeling sick10.2%
Vomitingbeing sick10.2%

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

In context

MeasureT Slim X2 Insulin Pump With Interoperable Technology With T Connect Mobile ApProduct code QFGAll MAUDE reports
Reports4531,297,99526,136,888
Share of that pool—0%0%
Classified as death, per 1,000 reports009
Classified as injury18.3%11.1%36.2%
Classified as malfunction81.7%88.9%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 QFG

BrandReportsLatest 12 monthsClassified as death
t:slim X2 Insulin Pump with Control-IQ Technology584,236129,1190%
t:slim X2 Insulin Pump with Interoperable Technology (with t:connect mobile app)267,71611,5020%
Omnipod 5 Pod72,51613,9130.1%
t:slim X2 Insulin Pump with Control-IQ+ Technology65,29857,9360%
iLet Bionic Pancreas62,88760,7710.1%
Omnipod 5 Pods53,25334,5930%
Omnipod 5 Automated Insulin Delivery System50,52332,4780%
t:slim X2 Insulin Pump with Interoperable Technology37,1368650%
Tandem Mobi Insulin Pump with Control-IQ+ Technology36,50631,6740%
Tandem Mobi Insulin Pump with Interoperable Technology27,9521,5950%
Tandem Mobi Insulin Pump with Control-IQ Technology15,1549,5530%
MiniMed 780G US System BLE Connect 3.0 mg/dL112,81757,1400.1%
t:slim X2 Insulin Pump with Basal-IQ Technology142,6411,9160%
Omnipod 5 Controller2,6189260.8%
T Slim X2 Insulin Pump With Interoperable Technology With T Connect Mobile A2,55500%

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 T Slim X2 Insulin Pump With Interoperable Technology With T Connect Mobile Ap reports

How many FDA reports name T Slim X2 Insulin Pump With Interoperable Technology With T Connect Mobile Ap?

453 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 (81.7%) and injury (18.3%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.

What device problems are coded?

charging problem (25.8%), pumping stopped (18.5%), incorrect measurement (10.2%), mechanical problem (6.6%) and filling problem (5.5%). 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 T Slim X2 Insulin Pump With Interoperable Technology With T Connect Mobile Ap 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.