t:flex Insulin Pump, Replacement 007516Recalls & reported problems
Tandem Diabetes Care, Inc. · Assembly, Pump Replacement, t:flex · Class 2
Quick summary
This Tandem t:flex insulin pump is a wearable device that delivers insulin for diabetes treatment. Most of its 495 reports describe the pump stopping, battery problems, charging problems and incorrect readings. Many reports say the patient was not affected, though some describe high or low blood sugar. The reports include 55 injuries and no deaths. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 495
- Deaths reported
- 0
- Injuries reported
- 55
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 495 adverse event reports that list this exact device (DI 00852162004576), received between Nov 16, 2017 and Jul 19, 2024 — classified as 55 injuries, 440 malfunctions.
The most frequently reported specific device problem is “Incorrect Measurement” (107 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Incorrect Measurement107
- Pumping Stopped87
- Battery Problem75
- Charging Problem57
- Obstruction of Flow53
- Failure to Sense29
- Adverse Event Without Identified Device or Use Problem27
- Device Displays Incorrect Message25
Patient problems
- No Consequences Or Impact To Patient242
- No Known Impact Or Consequence To Patient131
- No Clinical Signs, Symptoms or Conditions68
- Hyperglycemia27
- Hypoglycemia23
- Elevated Ketones/ Diabetic Ketoacidosis6
- Renal Failure2
- Insufficient Information1
Recent adverse event reports
The 25 most recent of 495 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 19, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT THERE WAS "TOTAL PUMP FAILURE". THERE WAS NO REPORTED IMPACT TO THE CUSTOMER'S BLOOD GLUCOSE LEVEL. NO ADDITIONAL PRODUCT OR EVENT INFORMATION WAS AVAILABLE DUE TO CUSTOMER DECLINING ADDITIONAL TROUBLESHOOTING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19784425 ↗MalfunctionNov 22, 2023Battery Problem; Battery Problem
IT WAS REPORTED THAT THE PUMP BATTERY WAS DEPLETING QUICKLY. CUSTOMER DECLINED FOLLOW UP FROM TANDEM TECHNICAL SUPPORT. THERE WAS NO REPORTED ADVERSE IMPACT. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18191233 ↗MalfunctionOct 9, 2023Incorrect Measurement; Obstruction of Flow; Incorrect Measurement; Obstruction of Flow
IT WAS REPORTED THAT THE INSULIN GAUGE WAS INACCURATE. ADDITIONALLY, IT WAS REPORTED THAT INTERMITTENT OCCLUSION ALARMS OCCURRED. THERE WAS NO REPORTED ADVERSE IMPACT TO THE CUSTOMER'S BLOOD GLUCOSE LEVEL. CUSTOMER DECLINED TO TROUBLESHOOT WITH TANDEM TECHNICAL SUPPORT, THEREFORE NO ADDITIONAL INFORMATION COULD BE OBTAINED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17894678 ↗MalfunctionSep 6, 2023Battery Problem; Battery Problem
IT WAS REPORTED THAT THE PUMP BATTERY WAS DEPLETING QUICKLY. THERE WAS NO REPORTED ADVERSE IMPACT TO THE CUSTOMER¿S BLOOD GLUCOSE LEVEL. THE CUSTOMER DECLINED FOLLOW-UP TROUBLESHOOTING WITH TANDEM TECHNICAL SUPPORT, THEREFORE NO ADDITIONAL INFORMATION COULD BE OBTAINED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17693124 ↗MalfunctionJun 8, 2023Battery Problem; Battery Problem
IT WAS REPORTED THAT THE PUMP BATTERY WAS DEPLETING QUICKLY. THERE WAS NO REPORTED IMPACT TO BLOOD GLUCOSE. CUSTOMER DECLINED TROUBLESHOOTING WITH TANDEM TECHNICAL SUPPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17088317 ↗MalfunctionMay 31, 2023Break; Difficult to Insert; Fitting Problem; Break; Difficult to Insert; Fitting Problem
IT WAS REPORTED THAT DAMAGE TO THE PUMP HOUSING CAUSED DIFFICULTY LOADING AND UNLOADING CARTRIDGES. THERE WAS NO REPORTED ADVERSE IMPACT TO CUSTOMER¿S BLOOD GLUCOSE LEVELS. CUSTOMER DECLINED TO PROVIDE ANY ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17030444 ↗MalfunctionApr 27, 2023Device Sensing Problem; Device Sensing Problem
IT WAS REPORTED THAT THE WAKE BUTTON WAS STICKING. THERE WAS NO IMPACT TO THE CUSTOMER¿S BLOOD GLUCOSE. REPORTEDLY THE CUSTOMER CONTINUED TO USE THE PUMP FOR INSULIN THERAPY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16824642 ↗MalfunctionMar 27, 2023False Alarm; False Alarm
IT WAS REPORTED THAT THE PUMP WAS NOT EXPOSED TO EXTREME TEMPERATURES, BUT A TEMPERATURE ALARM OCCURRED. CUSTOMER WAS UNABLE TO CLEAR THE ALARM AND REVERTED TO AN ALTERNATE METHOD OF INSULIN THERAPY. CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 317 MG/DL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16618439 ↗MalfunctionMar 2, 2023Failure to Sense; Obstruction of Flow; Battery Problem; Failure to Sense; Obstruction of Flow; Battery Problem
IT WAS REPORTED THAT OCCLUSION ALARMS OCCURRED. ADDITIONALLY, IT WAS REPORTED THAT THE PUMP TOUCH SCREEN WAS UNRESPONSIVE AND "FREEZES UP DURING BOLUSING." AS WELL, THAT THE PUMP BATTERY WAS DEPLETING QUICKLY AND THAT THE CUSTOMER EXPERIENCED ¿ISSUES CHARGING¿. THERE WAS NO ADVERSE IMPACT TO CUSTOMER'S BLOOD GLUCOSE. THE CUSTOMER DECLINED FOLLOW UP FROM TANDEM TECHNICAL SUPPORT, THEREFORE FURTHER INFORMATION WAS UNABLE TO BE OBTAINED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16469086 ↗MalfunctionNov 23, 2022Incorrect Measurement; Incorrect Measurement
IT WAS REPORTED THAT THE BATTERY GAUGE WAS FLUCTUATING. THE CUSTOMER DECLINED FOLLOW-UP FROM TANDEM TECHNICAL SUPPORT REGARDING THE ISSUE, THEREFORE NO ADDITIONAL INFORMATION WAS OBTAINED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15852433 ↗MalfunctionNov 17, 2022Pumping Stopped; Pumping Stopped
IT WAS REPORTED THAT A MALFUNCTION ALARM OCCURRED. DURING TROUBLESHOOTING WITH TANDEM TECHNICAL SUPPORT, THE MALFUNCTION ALARM WAS CLEARED, AND INSULIN DELIVERY WAS RESUMED SUCCESSFULLY. CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 390 MG/DL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15816632 ↗MalfunctionOct 13, 2022Fitting Problem; Fitting Problem
IT WAS REPORTED THAT A CARTRIDGE DID NOT FIT ONTO THE PUMP. CUSTOMER DECLINED TO TROUBLESHOOT THE ISSUE WITH TANDEM TECHNICAL SUPPORT, THEREFORE NO ADDITIONAL INFORMATION WAS OBTAINED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15594324 ↗MalfunctionSep 9, 2022Pumping Stopped; Pumping Stopped
IT WAS REPORTED THAT A CARTRIDGE ALARM OCCURRED DURING THE LOAD SEQUENCE WITH MULTIPLE CARTRIDGES. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 200 MG/DL. REPORTEDLY, THE CUSTOMER REVERTED TO AN ALTERNATE METHOD OF INSULIN THERAPY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15392363 ↗MalfunctionJul 6, 2022Date/Time-Related Software Problem; Date/Time-Related Software Problem
IT WAS REPORTED THAT THE PUMP TIME WAS INCORRECT, CAUSE WAS UNKNOWN. CUSTOMER REPORTED A BLOOD GLUCOSE LEVEL OF 170 MG/DL. DURING TROUBLESHOOTING WITH TANDEM TECHNICAL SUPPORT, THE CUSTOMER CORRECTED THE TIME AND RESUMED INSULIN THERAPY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14935091 ↗MalfunctionJun 23, 2022Pumping Stopped; Pumping Stopped
IT WAS REPORTED THAT A CARTRIDGE ALARM OCCURRED DURING BASAL DELIVERY. THERE WAS NO REPORTED IMPACT TO THE CUSTOMER'S BLOOD GLUCOSE LEVEL. REPORTEDLY, THE CUSTOMER CLEARED THE ALARM AND RESUMED INSULIN THERAPY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14788202 ↗MalfunctionJun 20, 2022Pumping Stopped; Pumping Stopped
IT WAS REPORTED THAT A MALFUNCTION ALARM OCCURRED. DURING TROUBLESHOOTING WITH TANDEM TECHNICAL SUPPORT, THE MALFUNCTION ALARM WAS CLEARED, AND INSULIN DELIVERY WAS RESUMED SUCCESSFULLY. CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 220 MG/DL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14748401 ↗MalfunctionJun 15, 2022Mechanical Problem; Mechanical Problem
IT WAS REPORTED THAT INTERMITTENT CARTRIDGE ALARMS OCCURRED. REPORTEDLY, THE CUSTOMER REVERTED TO ALTERNATE METHOD OF INSULIN THERAPY. CUSTOMER'S BLOOD GLUCOSE WAS 174 MG/DL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14698180 ↗MalfunctionMar 31, 2022Pumping Stopped; Pumping Stopped
IT WAS REPORTED THAT A MALFUNCTION ALARM OCCURRED. DURING TROUBLESHOOTING WITH TANDEM TECHNICAL SUPPORT, THE MALFUNCTION ALARM WAS CLEARED, AND INSULIN DELIVERY WAS RESUMED SUCCESSFULLY. CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 210 MG/DL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13967005 ↗MalfunctionMar 25, 2022Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT THE PUMP "COMPLETELY FAILED". THERE WAS NO REPORTED ADVERSE IMPACT TO THE CUSTOMER'S BLOOD GLUCOSE LEVEL. ATTEMPTS WERE MADE BY TANDEM TECHNICAL SUPPORT TO FOLLOW UP, HOWEVER NO ADDITIONAL INFORMATION WAS ABLE TO BE OBTAINED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13901600 ↗MalfunctionMar 24, 2022Incorrect Measurement; Mechanical Problem; Incorrect Measurement; Mechanical Problem
IT WAS REPORTED THAT A CARTRIDGE CHANGE ERROR OCCURRED AND THAT THE INSULIN GAUGE WAS INTERMITTENTLY INACCURATE. NO FURTHER INFORMATION WAS OBTAINED AS CUSTOMER DECLINED TROUBLESHOOTING WITH TANDEM TECHNICAL SUPPORT. THERE WAS NO REPORTED IMPACT TO BLOOD GLUCOSE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13894415 ↗MalfunctionMar 23, 2022Crack; Poor Quality Image; Crack; Poor Quality Image
IT WAS REPORTED THAT THE PUMP TOUCH SCREEN WAS CRACKED AND UNREADABLE. THERE WAS NO ADVERSE IMPACT TO THE CUSTOMER¿S BLOOD GLUCOSE LEVEL DUE TO THIS REPORTED EVENT. THE CUSTOMER DECLINED FURTHER TROUBLESHOOTING WITH TANDEM TECHNICAL SUPPORT, THEREFORE NO ADDITIONAL INFORMATION COULD BE OBTAINED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13862409 ↗MalfunctionMar 15, 2022Charging Problem; Charging Problem
IT WAS REPORTED THAT THE PUMP BATTERY COULD NOT BE CHARGED. THERE WAS NO ADVERSE IMPACT TO CUSTOMER¿S BLOOD GLUCOSE LEVEL. THE CUSTOMER REVERTED TO AN ALTERNATE METHOD OF INSULIN THERAPY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13772903 ↗MalfunctionMar 10, 2022Battery Problem; Battery Problem
IT WAS REPORTED THAT THE PUMP BATTERY DID NOT TURN ON. THERE WAS NO REPORTED ADVERSE IMPACT TO CUSTOMER¿S BLOOD GLUCOSE LEVEL. THE CUSTOMER DECLINED TROUBLESHOOTING WITH TANDEM TECHNICAL SUPPORT AND FURTHER INFORMATION WAS UNABLE TO BE OBTAINED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13721662 ↗MalfunctionMar 8, 2022Pumping Stopped; Failure to Sense; Pumping Stopped; Failure to Sense
IT WAS REPORTED THAT A MALFUNCTION ALARM OCCURRED. ADDITIONALLY, IT WAS REPORTED THAT THE PUMP TOUCH SCREEN WAS UNRESPONSIVE. CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 143 MG/DL. REPORTEDLY, THE CUSTOMER REVERTED TO ALTERNATE INSULIN THERAPY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13697868 ↗MalfunctionFeb 17, 2022Charging Problem; Charging Problem
IT WAS REPORTED THAT THE PUMP BATTERY COULD NOT BE CHARGED. CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 89 MG/DL. REPORTEDLY, THE CUSTOMER CONTINUED TO USE THE PUMP FOR INSULIN THERAPY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13550122 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.