t:flex Insulin Pump 005365Recalls & reported problems

Summary

The FDA's MAUDE database contains 1,211 adverse event reports that list this exact device (DI 00852162004385), received between Jul 6, 2018 and Oct 8, 2024 — classified as 1 death, 115 injuries, 1,095 malfunctions.

The most frequently reported specific device problem is “Pumping Stopped” (286 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 1,211 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 8, 2024Pumping Stopped; Pumping Stopped

  IT WAS REPORTED THAT A MALFUNCTION ALARM OCCURRED. DURING TROUBLESHOOTING WITH TECHNICAL SUPPORT, THE MALFUNCTION ALARM WAS CLEARED, AND INSULIN DELIVERY WAS RESUMED SUCCESSFULLY. THERE WAS NO ADVERSE IMPACT TO THE CUSTOMER¿S BLOOD GLUCOSE LEVEL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20401513 ↗
• InjuryAug 23, 2024Charging Problem; Charging Problem

  IT WAS REPORTED THAT THE PUMP BATTERY COULD NOT BE CHARGED. THE CUSTOMER'S BLOOD GLUCOSE (BG) LEVEL WAS "HIGH", ALTHOUGH A SPECIFIC VALUE WAS NOT GIVEN. THE CUSTOMER ADMINISTERED A MANUAL INJECTION TO ADDRESS THEIR BG. THE CUSTOMER DECLINED FOLLOW-UP FROM TANDEM TECHNICAL SUPPORT REGARDING THE ISSUE, THEREFORE NO ADDITIONAL INFORMATION WAS OBTAINED.

  Patient problems: Hyperglycemia

  MAUDE report 20047596 ↗
• MalfunctionAug 6, 2024Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT THE CUSTOMER RECEIVED A CONTINUOUS GLUCOSE MONITOR ERROR 42. THE PUMP WAS RESET, AND THE CUSTOMER CONTINUED TO USE THE PUMP FOR INSULIN THERAPY. THERE WAS NO REPORTED ADVERSE IMPACT TO THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19918602 ↗
• MalfunctionJan 29, 2024Crack; Failure to Sense; Device Sensing Problem; Crack; Failure to Sense; Device Sensing Problem

  IT WAS REPORTED THAT THE WAKE BUTTON WAS STICKING AND THAT THE TOUCH SCREEN WAS CRACKED AND UNRESPONSIVE. THERE WAS NO REPORTED ADVERSE EFFECT TO THE CUSTOMER'S BLOOD GLUCOSE LEVEL. CUSTOMER DECLINED TO TROUBLESHOOT THE ISSUE WITH TANDEM TECHNICAL SUPPORT; THEREFORE THE ALLEGATION COULD NOT BE CONFIRMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18594802 ↗
• MalfunctionDec 13, 2023Incorrect Measurement; Date/Time-Related Software Problem; Battery Problem; Incorrect Measurement; Date/Time-Related Software Problem; Battery Problem

  IT WAS REPORTED THAT THE PUMP BATTERY WAS DEPLETING QUICKLY. ADDITIONALLY, IT WAS REPORTED THAT THE PUMP TIME WAS INCORRECT, CAUSE WAS UNKNOWN. IT WAS ALSO REPORTED THAT THE INSULIN GAUGE WAS INACCURATE. THERE WAS NO REPORTED IMPACT TO THE CUSTOMER'S BLOOD GLUCOSE LEVEL. NO ADDITIONAL INFORMATION WAS PROVIDED AND THE CUSTOMER DECLINED TROUBLESHOOTING WITH TANDEM TECHNICAL SUPPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18318357 ↗
• MalfunctionJul 14, 2023Overheating of Device; Battery Problem; Device Sensing Problem; Overheating of Device; Battery Problem; Device Sensing Problem

  IT WAS REPORTED THAT THE PUMP BATTERY WAS DEPLETING QUICKLY AND THAT THE WAKE BUTTON WAS STICKING. ADDITIONALLY, IT WAS REPORTED THAT THE PUMP WAS WARM TO THE TOUCH DESPITE BEING IN ROOM-TEMPERATURE CONDITIONS. REPORTEDLY, THE PUMP WAS CHARGING DURING THE EVENT. 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 17326379 ↗
• MalfunctionJun 26, 2023Pumping Stopped; Pumping Stopped

  IT WAS REPORTED THAT INTERMITTENT, UNDEFINED ALARMS OCCURRED. THERE WAS NO REPORTED IMPACT TO THE CUSTOMER'S BLOOD GLUCOSE LEVEL. ADDITIONAL INFORMATION WAS NOT PROVIDED. THE CUSTOMER DECLINED FURTHER FOLLOW UP FROM TANDEM TECHNICAL SUPPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17197390 ↗
• MalfunctionJun 7, 2023Pumping Stopped; Pumping Stopped

  IT WAS REPORTED THAT AN UNSPECIFIED MALFUNCTION ALARM OCCURRED. 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 17083631 ↗
• MalfunctionMay 25, 2023Pumping Stopped; Pumping Stopped

  IT WAS REPORTED THAT A MALFUNCTION ALARM OCCURRED. THE CUSTOMER REVERTED TO MANUAL INJECTIONS FOR INSULIN THERAPY. CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 302 MG/DL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17004823 ↗
• MalfunctionMay 24, 2023Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT THE INSULIN GAUGE WAS INACCURATE. CUSTOMER RELOADED THE CARTRIDGE TO RESOLVE THE ISSUE. THERE WAS NO REPORTED ADVERSE IMPACT TO THE CUSTOMER¿S BLOOD GLUCOSE LEVEL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16993765 ↗
• InjuryMay 18, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE CUSTOMER'S BG VALUE DISPLAYED AS 'LOW' ON THE CONTINUOUS GLUCOSE MONITOR (CGM). CAUSE OF LOW BG WAS UNKNOWN. THE CUSTOMER CONSUMED CARBOHYDRATES TO ADDRESS BG. RECOMMENDATION WAS MADE TO CONSULT WITH A HEALTHCARE PROVIDER TO DISCUSS DIABETES MANAGEMENT.

  Patient problems: Hypoglycemia

  MAUDE report 16952967 ↗
• MalfunctionApr 14, 2023Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT THE INSULIN GAUGE WAS INACCURATE. 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 16744078 ↗
• MalfunctionApr 13, 2023Battery Problem; Device Sensing Problem; Battery Problem; Device Sensing Problem

  IT WAS REPORTED THAT THE PUMP BATTERY WAS DEPLETING QUICKLY AND THAT THE WAKE BUTTON WAS STICKING. CUSTOMER DECLINED TO TROUBLESHOOT THE ISSUE WITH TANDEM TECHNICAL SUPPORT; THEREFORE THE ALLEGATION COULD NOT BE CONFIRMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16732537 ↗
• MalfunctionMar 28, 2023Poor Quality Image; Charging Problem; Poor Quality Image; Charging Problem

  IT WAS REPORTED THAT THE PUMP BATTERY "CHARGES SLOWLY." ADDITIONALLY, IT WAS REPORTED THAT THE PUMP TOUCH SCREEN WAS UNREADABLE. REPORTEDLY, THE SCREEN WAS DISTORTED WHICH BLOCKED GRAPHICS AND TEXT. 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 16628227 ↗
• MalfunctionJan 6, 2023Poor Quality Image; Battery Problem; Charging Problem; Poor Quality Image; Battery Problem; Charging Problem

  IT WAS REPORTED THAT THE PUMP TOUCHSCREEN DISPLAY WITH "DIM". ADDITIONALLY, IT WAS REPORTED THAT THE PUMP USB PORT WAS DAMAGED RESULTING IN DIFFICULTIES CHARGING THE PUMP. AS WELL, AS THAT THE PUMP BATTERY WAS DEPLETING QUICKLY. 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 16112641 ↗
• MalfunctionDec 27, 2022Incorrect Measurement; Pumping Stopped; Incorrect Measurement; Pumping Stopped

  IT WAS REPORTED THAT THE INSULIN GAUGE WAS INACCURATE. ADDITIONALLY, IT WAS REPORTED THAT UNSPECIFIED MALFUNCTION ALARMS OCCURRED. THERE WAS NO ADVERSE IMPACT TO CUSTOMERS 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 16051573 ↗
• MalfunctionDec 21, 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. CUSTOMERS BLOOD GLUCOSE LEVEL WAS APPROXIMATELY 200 MG/DL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16030064 ↗
• MalfunctionDec 20, 2022Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT THE BATTERY GAUGE WAS FLUCTUATING. 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 16013526 ↗
• MalfunctionNov 10, 2022Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT INTERMITTENT OCCLUSION ALARMS OCCURRED. THE CUSTOMER CHANGED SUPPLIES TO ADDRESS THE ISSUE. THERE WAS NO REPORTED ADVERSE IMPACT TO THE CUSTOMER¿S BLOOD GLUCOSE LEVEL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15771343 ↗
• MalfunctionNov 3, 2022Pumping Stopped; Pumping Stopped

  IT WAS REPORTED THAT THE PUMP "TOTALLY FAILED." THERE WAS NO REPORTED ADVERSE IMPACT TO THE CUSTOMER'S BLOOD GLUCOSE LEVEL. REPORTEDLY, THE CUSTOMER DECLINED FOLLOW-UP FROM TANDEM TECHNICAL SUPPORT TO COMPLETE TROUBLESHOOTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15723453 ↗
• MalfunctionNov 2, 2022Charging Problem; Charging Problem

  IT WAS REPORTED THAT THE PUMP BATTERY COULD NOT BE CHARGED. CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 122 MG/DL. THE CUSTOMER REVERTED TO AN ALTERNATE METHOD OF INSULIN THERAPY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15715209 ↗
• MalfunctionOct 25, 2022Battery Problem; Battery Problem

  IT WAS REPORTED THAT THE PUMP BATTERY WAS DEPLETING QUICKLY. CUSTOMER DECLINED TROUBLESHOOTING 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 15666614 ↗
• MalfunctionOct 20, 2022Battery Problem; Material Twisted/Bent; Battery Problem; Material Twisted/Bent

  IT WAS REPORTED THAT THE PUMP BATTERY WAS DEPLETING QUICKLY. ADDITIONALLY, IT WAS REPORTED THAT THE PUMP USB PORT WAS DAMAGED AND BENT. CUSTOMER DECLINED TROUBLESHOOTING 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 15641140 ↗
• MalfunctionOct 7, 2022Battery 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. 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 15564326 ↗
• MalfunctionOct 1, 2022Pumping Stopped; Pumping Stopped

  IT WAS REPORTED THAT THE PUMP "COMPLETELY FAILED." THERE WAS NO REPORTED ADVERSE IMPACT TO THE CUSTOMER'S BLOOD GLUCOSE LEVEL. THE CUSTOMER REVERTED TO AN ALTERNATE METHOD OF INSULIN THERAPY. REPORTEDLY, THE CUSTOMER DECLINED FOLLOW-UP FROM TANDEM TECHNICAL SUPPORT TO COMPLETE TROUBLESHOOTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15526029 ↗