t:slim G4 Insulin Pump, Reconditioned 008542Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00852162004750), received between Nov 5, 2019 and Apr 15, 2022 — classified as 2 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Charging Problem” (2 reports).

1 other recall cover devices cleared under the same FDA submission (P140015); they may or may not involve this specific model.

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.

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 15, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE "PUMP FAILED". THERE WAS NO REPORTED ADVERSE IMPACT TO THE CUSTOMER'S BLOOD GLUCOSE LEVEL. 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 14118126 ↗
• InjuryDec 23, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE CUSTOMER EXPERIENCED A BLOOD GLUCOSE (BG) LEVEL OF 610 MG/DL. THE CAUSE OF ELEVATED BG WAS UNKNOWN. THE CUSTOMER WENT TO THE EMERGENCY ROOM AND WAS SUBSEQUENTLY HOSPITALIZED IN THE INTENSIVE CARE UNIT. BG WAS TREATED WITH INTRAVENOUS INSULIN AND SALINE. REPORTEDLY, THE CUSTOMER WAS RELEASED ON (B)(6) 2021 WITH THE ISSUE RESOLVED AND NO PERMANENT DAMAGE. SYSTEM CHECK WITH TANDEM TECHNICAL SUPPORT CONFIRMED THE PUMP WAS FUNCTIONING AS INTENDED.

  Patient problems: Hyperglycemia

  MAUDE report 13082569 ↗
• MalfunctionDec 15, 2021Date/Time-Related Software Problem; Date/Time-Related Software Problem

  IT WAS REPORTED THAT THE PUMP TIME WAS INCORRECT, CAUSE WAS UNKNOWN. THERE WAS NO ADVERSE IMPACT TO CUSTOMER'S BLOOD GLUCOSE LEVEL. 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 13011827 ↗
• MalfunctionFeb 18, 2021Incorrect Measurement; Charging Problem; Incorrect Measurement; Charging Problem

  IT WAS REPORTED THAT THE BATTERY GAUGE WAS FLUCTUATING. ADDITIONALLY, IT WAS REPORTED THAT THE CUSTOMER EXPERIENCED DIFFICULTIES CHARGING THE PUMP. THERE WAS NO REPORTED IMPACT TO THE CUSTOMER¿S BLOOD GLUCOSE LEVEL. CUSTOMER DECLINED TROUBLESHOOTING WITH TANDEM TECHNICAL SUPPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11343933 ↗
• InjuryJan 29, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE CUSTOMER WAS HOSPITALIZED. REPORTEDLY PER CONTACT, CUSTOMER LEFT INFUSION SET IN FOR TOO LONG. CONTACT DECLINED TO PROVIDE ADDITIONAL INFORMATION REGARDING THE REPORTED ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 11254496 ↗
• MalfunctionNov 4, 2020Device Sensing Problem; Device Sensing Problem

  IT WAS REPORTED THAT THE WAKE BUTTON WAS UNRESPONSIVE. CUSTOMER CONFIRMED PUMP DISPLAY TURNED ON WHEN PLUGGED INTO A POWER SOURCE. CUSTOMER¿S BLOOD GLUCOSE WAS 122 MG/DL. REPORTEDLY, CUSTOMER CONTINUED TO USE THE PUMP FOR INSULIN THERAPY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10785202 ↗
• MalfunctionJun 24, 2020Inappropriate or Unexpected Reset; Inappropriate or Unexpected Reset

  IT WAS REPORTED THAT AN UNEXPECTED RESET OCCURRED. THERE WAS NO REPORTED IMPACT TO THE CUSTOMER'S BLOOD GLUCOSE LEVEL. REPORTEDLY, THE CUSTOMER DECLINED TO PROVIDE ADDITIONAL INFORMATION AND FURTHER TROUBLESHOOTING WITH TANDEM TECHNICAL SUPPORT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10190186 ↗
• MalfunctionJun 12, 2020Charging Problem; Charging Problem

  IT WAS REPORTED THAT THE CUSTOMER EXPERIENCED AN ISSUE WITH CHARGING THE PUMP BATTERY. THERE WAS NO REPORTED IMPACT TO THE CUSTOMER¿S BLOOD GLUCOSE LEVEL. THE CUSTOMER DECLINED FOLLOW UP FROM TANDEM TECHNICAL SUPPORT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10150585 ↗
• MalfunctionFeb 25, 2020Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT INTERMITTENT OCCLUSION ALARMS OCCURRED. SYSTEM CHECK WAS PERFORMED WITH TANDEM TECHNICAL SUPPORT AND THE CAUSE COULD NOT BE DETERMINED. CUSTOMER'S BLOOD GLUCOSE WAS 148 MG/DL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9752240 ↗
• MalfunctionDec 2, 2019Pumping Stopped; Pumping Stopped

  IT WAS REPORTED THAT A MALFUNCTION ALARM OCCURRED. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 137 MG/DL. DURING TROUBLESHOOTING WITH TANDEM TECHNICAL SUPPORT, THE MALFUNCTION ALARM WAS CLEARED, AND INSULIN DELIVERY WAS ABLE TO BE RESUMED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9398236 ↗
• MalfunctionNov 5, 2019Pumping 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 VALUE WAS 170 MG/DL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9282513 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P140015. One submission often covers many models, so check the product and lot details in each record.

• Z-2471-2018 · Apr 23, 2018 · Open, Classified
  t:slim G4 Insulin Pump with Dexcom G4 Platinum CGM Software version: 4.3.4.3, Firmware version: 004722, Firmware, Fuel Gauge, Binary Rev B.