t:slim Insulin Pump, Demonstration 007445Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00852162004590), received between Mar 21, 2019 and Jun 20, 2025 — classified as 12 malfunctions.

The most frequently reported specific device problem is “Device Sensing Problem” (5 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 20, 2025Pumping Stopped; Pumping Stopped

  PUMPS RETURNED FROM A CLINICAL TRIAL WERE REPORTED TO HAVE MAL-16 FAILURES AND WERE FLAGGED FOR QUALITY ISSUES. THERE WAS NO ADVERSE IMPACT TO THE CUSTOMER'S BLOOD GLUCOSE LEVEL. THE PUMPS WERE QUARANTINED BY THE QA TEAM ONCE THE RETURN PROCESS WAS INITIATED AND COMPLETED, AND THE LIST OF PUMPS WAS UPDATED TO REFLECT THE CORRECT NUMBER INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22298679 ↗
• MalfunctionJun 25, 2024Pumping Stopped; Pumping Stopped

  IT WAS REPORTED THAT A MALFUNCTION ALARM OCCURRED. THERE WAS NO PATIENT INVOLVEMENT, AS THE PUMP WAS BEING USED FOR DEMONSTRATION PURPOSES ONLY. THERE WAS NO ADVERSE IMPACT TO THE CUSTOMER¿S BLOOD GLUCOSE LEVEL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19608592 ↗
• MalfunctionMar 6, 2024Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT AN OCCLUSION ALARM OCCURRED. THERE WAS NO ADVERSE IMPACT TO CUSTOMER¿S BLOOD GLUCOSE LEVEL. 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 18847521 ↗
• MalfunctionMay 14, 2021Pumping Stopped; Charging Problem; Pumping Stopped; Charging Problem

  IT WAS REPORTED THAT AN UNSPECIFIED MALFUNCTION ALARM OCCURRED AND THAT THE BATTERY COULD NOT BE CHARGED. THERE WAS NO IMPACT TO BLOOD GLUCOSE AS THE PUMP WAS A DEMO AND NOT BEING USED FOR INSULIN THERAPY. MULTIPLE FOLLOW-UP ATTEMPTS WERE MADE BY TANDEM TECHNICAL SUPPORT TO COMPLETE TROUBLESHOOTING; HOWEVER, NO RESPONSE WAS RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11826045 ↗
• MalfunctionJan 29, 2021Device Sensing Problem; Device Sensing Problem

  IT WAS REPORTED THAT THE WAKE BUTTON WAS UNRESPONSIVE. PUMP DISPLAY TURNED ON WHEN PLUGGED INTO A POWER SOURCE. THERE WAS NO ADVERSE IMPACT AS PUMP WAS USED FOR DEMONSTRATION PURPOSES ONLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11252257 ↗
• MalfunctionDec 5, 2020Charging Problem; Charging Problem

  IT WAS REPORTED THAT THE PUMP BATTERY COULD NOT BE CHARGED. THERE WAS NO PATIENT INVOLVEMENT, AS THE PUMP WAS BEING USED FOR DEMONSTRATION AND WAS NOT BEING USED ON A CUSTOMER AT THE TIME OF THE REPORTED EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 10951212 ↗
• MalfunctionApr 10, 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. THIS PUMP IS BEING USED FOR DEMO AND NOT BEING USED BY CUSTOMER AT TIME OF EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 9948695 ↗
• MalfunctionMar 26, 2020False Alarm; False Alarm

  IT WAS REPORTED THAT AN ALTITUDE ALARM OCCURRED WHILE THE CUSTOMER WAS NOT OUTSIDE OF THE LABELED OPERATING ALTITUDE RANGE. THERE WAS NO REPORTED IMPACT TO THE CUSTOMER'S BLOOD GLUCOSE LEVEL. REPORTEDLY, THE CUSTOMER CONTINUED TO USE THE PUMP FOR INSULIN THERAPY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9884202 ↗
• MalfunctionMar 18, 2020Device Sensing Problem; Device Sensing Problem

  IT WAS REPORTED THAT THE WAKE BUTTON WAS UNRESPONSIVE. THIS PUMP IS BEING USED FOR DEMO AND NOT BEING USED BY CUSTOMER AT TIME OF EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 9848299 ↗
• MalfunctionMar 10, 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. THIS PUMP IS BEING USED FOR DEMO AND NOT BEING USED BY CUSTOMER AT TIME OF EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 9813529 ↗
• MalfunctionFeb 12, 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. THIS PUMP IS BEING USED FOR DEMO AND NOT BEING USED BY CUSTOMER AT TIME OF EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 9699629 ↗
• MalfunctionMar 21, 2019False Alarm; Visual Prompts will not Clear; False Alarm; Visual Prompts will not Clear

  IT WAS REPORTED THAT AN ALTITUDE ALARM OCCURRED WHILE THE CUSTOMER WAS NOT OUTSIDE OF THE LABELED OPERATING ALTITUDE RANGE. THE PUMP WAS NOT USED FOR INSULIN THERAPY.

  Patient problems: No Patient Involvement

  MAUDE report 8441085 ↗