t:slim Insulin Pump, Reconditioned 007444Recalls & reported problems

Summary

The FDA's MAUDE database contains 284 adverse event reports that list this exact device (DI 00852162004378), received between Jul 6, 2018 and Oct 11, 2024 — classified as 40 injuries, 244 malfunctions.

The most frequently reported specific device problem is “Pumping Stopped” (55 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 284 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 11, 2024Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT THE INSULIN GAUGE WAS INACCURATE. CUSTOMER DECLINED FOLLOW UP FROM TANDEM TECHNICAL SUPPORT. THERE WAS NO REPORTED ADVERSE IMPACT TO THE CUSTOMER. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20427392 ↗
• MalfunctionDec 28, 2023Battery Problem; Battery Problem

  IT WAS REPORTED THAT THE PUMP BATTERY WAS DEPLETING QUICKLY. 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 18410044 ↗
• MalfunctionJun 9, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PUMP WAS NOT WORKING PROPERLY. THERE WAS NO REPORTED IMPACT 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 17097215 ↗
• MalfunctionJul 13, 2022Failure to Sense; Failure to Sense

  IT WAS REPORTED THAT THE PUMP TOUCH SCREEN WAS INTERMITTENTLY UNRESPONSIVE. 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 15000211 ↗
• MalfunctionJun 14, 2022Failure to Sense; Obstruction of Flow; Failure to Sense; Obstruction of Flow

  IT WAS REPORTED THAT THE PUMP TOUCH SCREEN WAS UNRESPONSIVE AND THAT AN OCCLUSION ALARM OCCURRED. 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 14685627 ↗
• InjuryApr 27, 2022Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  IT WAS REPORTED THAT THE PUMP WAS NOT DELIVERING INSULIN AS INTENDED WHICH RESULTED IN CUSTOMER BECOMING UNCONSCIOUS. MULTIPLE ATTEMPTS WERE MADE BY TANDEM TECHNICAL SUPPORT TO FOLLOW-UP WITH THE CUSTOMER ON THE REPORTED ISSUE, BUT NO RESPONSE WAS RECEIVED.

  Patient problems: Insufficient Information; Loss of consciousness

  MAUDE report 14218799 ↗
• InjuryApr 13, 2022Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT INTERMITTENT OCCLUSION ALARMS OCCURRED. CUSTOMER CHANGED THE PUMP SUPPLIES TO ADDRESS THE ISSUE. CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS "HIGH" ON THE CONTINUOUS GLUCOSE MONITOR (CGM), WITH MODERATE KETONES. ELEVATED BLOOD GLUCOSE LEVELS WERE ADDRESSED BY MANUAL INSULIN INJECTION. REPORTEDLY, THE CUSTOMER REVERTED TO AN ALTERNATE METHOD INSULIN THERAPY.

  Patient problems: Hyperglycemia

  MAUDE report 14101499 ↗
• MalfunctionFeb 4, 2022Failure to Sense; Device Sensing Problem; Failure to Sense; Device Sensing Problem

  IT WAS REPORTED THAT THE PUMP TOUCH SCREEN WAS UNRESPONSIVE AND THE WAKE BUTTON WAS STICKING. 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 13453762 ↗
• MalfunctionDec 28, 2021Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT INTERMITTENT OCCLUSION ALARMS OCCURRED. REPORTED THE CUSTOMER IS NOT PERFORMING THE AIR REMOVAL STEP PER USER GUIDE. CLINCIAL SUPPORT INFORMED CUSTOMER THAT NOT PERFORMING THE AIR REMOVAL STEP PER USER GUIDE IS OFF LABLE. CUSTOMER CHANGED THE PUMP SUPPLIES AND RESUMED INSULIN DELIVERY. CUSTOMER BLOOD GLUOCASE WAS 300 MG/DL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13095439 ↗
• InjuryDec 23, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE CUSTOMER WAS HOSPITALIZED IN THE INTENSIVE CARE UNIT DUE TO A BLOOD GLUCOSE (BG) LEVEL OF 1341MG/DL. THE CONTACT WAS UNABLE TO PROVIDE ADDITIONAL INFORMATION REGARDING THE REPORTED ISSUE. MULTIPLE CONTACT ATTEMPTS WERE MADE BY TANDEM TECHNICAL SUPPORT TO OBTAIN ADDITIONAL INFORMATION REGARDING THE EVENT; HOWEVER, NO RESPONSE WAS RECEIVED FROM THE CUSTOMER.

  Patient problems: Hyperglycemia

  MAUDE report 13082539 ↗
• InjuryDec 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE CUSTOMER WAS HOSPITALIZED; DETAILS AND NATURE OF HOSPITALIZATION WERE NOT PROVIDED. MULTIPLE CONTACT ATTEMPTS WERE MADE BY TANDEM TECHNICAL SUPPORT TO OBTAIN ADDITIONAL INFORMATION REGARDING THE EVENT; HOWEVER, NO RESPONSE WAS RECEIVED FROM THE CUSTOMER.

  Patient problems: Insufficient Information

  MAUDE report 13065095 ↗
• MalfunctionDec 2, 2021Battery 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 12919029 ↗
• MalfunctionNov 18, 2021Obstruction of Flow; Date/Time-Related Software Problem; Battery Problem; Obstruction of Flow; Date/Time-Related Software Problem; Battery Problem

  IT WAS REPORTED THAT THE PUMP BATTERY WAS DEPLETING QUICKLY, PUMP TIME AND DATE WERE INCORRECT, AND MULTIPLE INTERMITTENT OCCLUSION ALARMS OCCURRED. 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 12837015 ↗
• MalfunctionOct 1, 2021Failure to Sense; Failure to Sense

  IT WAS REPORTED THAT THE PUMP TOUCH SCREEN WAS CRACKED AND UNRESPONSIVE. THERE WAS NO REPORTED IMPACT TO THE CUSTOMER¿S BLOOD GLUCOSE LEVEL. THE CUSTOMER DECLINED TO TROUBLESHOOT WITH TANDEM TECHNICAL SUPPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12561263 ↗
• MalfunctionSep 22, 2021Incorrect Measurement; Battery Problem; Charging Problem; Incorrect Measurement; Battery Problem; Charging Problem

  IT WAS REPORTED THAT THE INSULIN GAUGE WAS INACCURATE. ADDITIONALLY, IT WAS REPORTED THAT THE PUMP BATTERY WAS DEPLETING QUICKLY AND COULD NOT BE CHARGED WITHOUT HOLDING THE CHARGING CABLE IN PLACE. CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 168-270 MG/DL. REPORTEDLY, THE CUSTOMER CONTINUED TO USE THE PUMP FOR INSULIN THERAPY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12516163 ↗
• InjurySep 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE CUSTOMER WENT TO THE EMERGENCY ROOM AND WAS SUBSEQUENTLY HOSPITALIZED DUE TO A LOW BLOOD GLUCOSE (BG) LEVEL OF 12 MG/DL. CAUSE OF LOW BG WAS UNKNOWN. CUSTOMER WAS TREATED WITH SUGAR WATER AND INTRAVENOUS FLUIDS OF SALINE AND INSULIN. REPORTEDLY, LOW BG RESULTED IN UNCONSCIOUSNESS AND NERVE DAMAGE IN CUSTOMER'S FOOT. CUSTOMER WAS RELEASED FROM THE HOSPITAL 15 DAYS LATER.

  Patient problems: Hypoglycemia; Loss of consciousness; Nerve Damage

  MAUDE report 12516148 ↗
• MalfunctionSep 7, 2021Battery 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 12434524 ↗
• MalfunctionAug 27, 2021Battery Problem; Battery Problem

  IT WAS REPORTED THAT THE PUMP BATTERY WAS DEPLETING QUICKLY. THERE WAS NO ADVERSE IMPACT TO BLOOD GLUCOSE. CUSTOMER DECLINED FURTHER TROUBLESHOOTING WITH TANDEM TECHNICAL SUPPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12378920 ↗
• MalfunctionAug 26, 2021Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT THE INSULIN GAUGE WAS INACCURATE. CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS APPROXIMATELY 160 MG/DL. CUSTOMER DECLINED FURTHER TROUBLESHOOTING WITH TANDEM TECHNICAL SUPPORT TO RESOLVE THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12373820 ↗
• InjuryAug 19, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE CUSTOMER REQUIRED ASSISTANCE TO TREAT A LOW BLOOD GLUCOSE LEVEL AND AN ELEVATED BLOOD GLUCOSE LEVEL (VALUE NOT PROVIDED). NO ADDITIONAL INFORMATION WAS PROVIDED. MULTIPLE CONTACT ATTEMPTS WERE MADE BY TANDEM TECHNICAL SUPPORT TO OBTAIN ADDITIONAL INFORMATION REGARDING THE EVENT; HOWEVER, NO RESPONSE WAS RECEIVED FROM THE CUSTOMER.

  Patient problems: Hyperglycemia; Hypoglycemia

  MAUDE report 12345329 ↗
• MalfunctionAug 19, 2021Battery 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 12344413 ↗
• MalfunctionAug 18, 2021Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT OCCLUSION ALARMS OCCURRED. SYSTEM CHECK WAS PERFORMED WITH TANDEM TECHNICAL SUPPORT AND THE ROOT CAUSE COULD NOT BE DETERMINED. CUSTOMER CHANGED PUMP SUPPLIES AND SUCCESSFULLY RESUMED INSULIN DELIVERY. THERE WAS NO ADVERSE IMPACT TO CUSTOMER'S BLOOD GLUCOSE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12337971 ↗
• MalfunctionAug 12, 2021Device Sensing Problem; Device Sensing Problem

  IT WAS REPORTED THAT THE WAKE BUTTON WAS STICKING. ADDITIONALLY, THE WAKE BUTTON WAS UNRESPONSIVE. THERE WAS NO REPORTED IMPACT TO THE CUSTOMER¿S BLOOD GLUCOSE. REPORTEDLY, THE CUSTOMER DECLINED TROUBLESHOOTING WITH TANDEM TECHNICAL SUPPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12314074 ↗
• MalfunctionJul 30, 2021Pumping 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 305 MG/DL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12252802 ↗
• MalfunctionJul 28, 2021Pumping Stopped; Pumping Stopped

  IT WAS REPORTED THAT THE PUMP STOPPED DELIVERING INSULIN. CUSTOMER REVERTED TO MANUAL INJECTIONS FOR INSULIN THERAPY. THERE WAS NO REPORTED ADVERSE IMPACT TO THE CUSTOMER¿S BLOOD GLUCOSE LEVEL. CUSTOMER DECLINED TROUBLESHOOTING WITH TANDEM TECHNICAL SUPPORT AND DECLINED TO PROVIDE FURTHER INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12239673 ↗