t:slim X2 Insulin Pump with Basal-IQ 1000912Recalls & reported problems

Summary

The FDA's MAUDE database contains 30,219 adverse event reports that list this exact device (DI 00853052007325), received between Nov 8, 2018 and Jul 7, 2026 — classified as 2 deaths, 2,720 injuries, 27,497 malfunctions.

The most frequently reported specific device problem is “Pumping Stopped” (6,484 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. May 24, 2022Open, Classified

   Insulin pumps may have the following issues: 1) Malfunction 6 Non-Volatile Memory, 2) Inaccurate (Fluctuating) Battery Life Display, 3) Touchscreen Staying On, 4) Unexpected Open Loop, that can be mitigated with a software update. Issues could result in hypoglycemia, hyperglycemia or diabetic ketoacidosis.

   Z-1811-2022 · Root cause: Device Design · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 30,219 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 7, 2026Fracture

  IT WAS REPORTED THAT THE PUMP TOUCH SCREEN WAS CRACKED AND UNRESPONSIVE AND UNREADABLE. THERE WAS NO ADVERSE IMPACT TO THE CUSTOMER¿S BLOOD GLUCOSE LEVEL. THE CUSTOMER REVERTED TO AN ALTERNATE METHOD IN INSULIN THERAPY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25736690 ↗
• MalfunctionJul 7, 2026False Alarm

  IT WAS REPORTED THAT AN ALTITUDE ALARM OCCURRED WHILE THE CUSTOMER WAS NOT OUTSIDE OF LABELED OPERATING ALTITUDE RANGE. THERE WAS NO ADVERSE IMPACT TO THE CUSTOMER¿S BLOOD GLUCOSE LEVEL. REPORTEDLY, THE CUSTOMER CLEANED THE SPEAKER HOLES AND CLEARED THE ALARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25735039 ↗
• MalfunctionJul 1, 2026Break; Charging Problem

  IT WAS REPORTED THAT INSULIN PUMP WAS DAMAGED AROUND CHARGING PORT, WHICH CAUSED INTERMITTENT TROUBLE WITH CHARGING. THERE WAS NO REPORTED IMPACT TO THE CUSTOMER¿S BLOOD GLUCOSE LEVEL. CUSTOMER DECLINED FURTHER FOLLOW UP, WAS OUT OF WARRANTY, AND WAS IN PROCESS OF PUMP RENEWAL, AND NO ADDITIONAL INFORMATION WAS RECEIVED REGARDING OUTCOME OF EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25677606 ↗
• MalfunctionJun 2, 2026Pumping Stopped

  IT WAS REPORTED THAT AN UNSPECIFIED MALFUNCTION ALARM OCCURRED. 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 25358680 ↗
• MalfunctionMay 28, 2026Fracture

  IT WAS REPORTED THAT PUMP SCREEN WAS CRACKED AND CONSIDERED A MALFUNCTION, AND CUSTOMER DECLINED TO SPEAK WITH CUSTOMER TECHNICAL SUPPORT. THERE WAS NO REPORTED IMPACT TO THE CUSTOMER¿S BLOOD GLUCOSE LEVEL. NO ADDITIONAL INFORMATION WAS RECEIVED REGARDING ANY ACTIONS TAKEN BY THE CUSTOMER OR TECHNICAL SUPPORT, AND NO FURTHER OUTCOME DETAILS WERE AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25322267 ↗
• MalfunctionMay 26, 2026Program or Algorithm Execution Problem

  IT WAS REPORTED THAT THE PUMP SOFTWARE DID NOT ACCURATELY ADJUST THE AMOUNT OF INSULIN DELIVERED. THERE WAS NO ADVERSE IMPACT TO THE CUSTOMER¿S BLOOD GLUCOSE LEVEL. REPORTEDLY, THE CUSTOMER DECLINED ASSISTANCE FROM TANDEM TECHNICAL SUPPORT REGARDING THE ISSUE. NO ADDITIONAL PATIENT OR EVENT INFORMATION WAS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25284237 ↗
• MalfunctionMay 26, 2026Premature Discharge of Battery

  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 FROM TANDEM TECHNICAL SUPPORT REGARDING THE ISSUE, THEREFORE NO ADDITIONAL INFORMATION WAS OBTAINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25280709 ↗
• MalfunctionMay 26, 2026Key or Button Unresponsive/not Working

  IT WAS REPORTED THAT THE WAKE BUTTON ON THE PUMP WAS UNRESPONSIVE INTERMITTENTLY. THERE WAS NO ADVERSE IMPACT TO THE CUSTOMER'S BLOOD GLUCOSE LEVEL. 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 25280365 ↗
• MalfunctionMay 22, 2026Premature Discharge of Battery

  IT WAS REPORTED THAT THE PUMP BATTERY WAS DEPLETING QUICKLY. 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 25257470 ↗
• MalfunctionMay 5, 2026Failure to Charge

  IT WAS REPORTED THAT THE CUSTOMER WAS UNABLE TO CHARGE THE PUMP USING THE TANDEM-PROVIDED USB CHARGING CABLE AND WALL POWER ADAPTER. THERE WAS NO ADVERSE IMPACT TO THE CUSTOMER¿S BLOOD GLUCOSE LEVEL. REPORTEDLY, THE CUSTOMER WAS ABLE TO SUCCESSFULLY CHARGE THE PUMP USING A SECONDARY USB CABLE AND WALL POWER ADAPTER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25081317 ↗
• MalfunctionApr 28, 2026Pumping Stopped

  IT WAS REPORTED THAT PUMP EXPERIENCED MALFUNCTION CODE 9 WITH NO NOTABLE EVENTS OCCURRING BEFOREHAND. THERE WAS NO ADVERSE IMPACT TO THE CUSTOMER¿S BLOOD GLUCOSE LEVEL. CUSTOMER CONTACTED TECHNICAL SUPPORT, RECEIVED INSTRUCTIONS TO RESET PUMP, SUCCESSFULLY RESET MALFUNCTION WITHOUT RECURRENCE, AND WAS ADVISED TO CONTINUE USING PUMP AND TO CALL BACK IF MALFUNCTION CODE APPEARED AGAIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25015327 ↗
• InjuryApr 21, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE CUSTOMER EXPERIENCED AN ELEVATED BLOOD GLUCOSE (BG) LEVEL OF 600 MG/DL. CAUSE WAS NOT KNOWN. CUSTOMER CHANGED SUPPLIES TO ADDRESS BG. RECOMMENDATION WAS MADE TO CONSULT WITH A HEALTHCARE PROVIDER REGARDING DIABETES MANAGEMENT.

  Patient problems: Hyperglycemia

  MAUDE report 24941890 ↗
• MalfunctionApr 13, 2026Failure to Charge

  IT WAS REPORTED THAT THE CUSTOMER RECEIVED A POWER SOURCE ALERT AFTER PLUGGING THE PUMP INTO A WALL OUTLET. THERE WAS NO REPORTED ADVERSE IMPACT TO THE CUSTOMER'S BLOOD GLUCOSE LEVEL. MULTIPLE CONTACT ATTEMPTS WERE MADE BY TANDEM TECHNICAL SUPPORT TO OBTAIN ADDITIONAL INFORMATION REGARDING THE ISSUE; HOWEVER, NO RESPONSE WAS RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24856040 ↗
• MalfunctionApr 6, 2026Pumping Stopped

  IT WAS REPORTED THAT PUMP MALFUNCTION OCCURRED INTERMITTENTLY. CUSTOMER¿S BLOOD GLUCOSE (BG) LEVEL WAS DISPLAYED AS "HIGH"; HOWEVER, SPECIFIC VALUE WAS NOT PROVIDED. ELEVATED BG WAS ADDRESS BY A MANUAL INSULIN INJECTION AND DID NOT REQUIRE ASSISTANCE FROM A THIRD PARTY. REPORTEDLY, THE CUSTOMER REVERTED TO AN ALTERNATE METHOD OF INSULIN THERAPY.

  Patient problems: Hyperglycemia

  MAUDE report 24792022 ↗
• MalfunctionFeb 6, 2026Premature Discharge of Battery

  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 ASSISTANCE FROM TANDEM TECHNICAL SUPPORT REGARDING THE ISSUE. NO ADDITIONAL PATIENT OR EVENT INFORMATION WAS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24279012 ↗
• MalfunctionFeb 6, 2026Premature Discharge of Battery

  CUSTOMER REPORTED BATTERY DEPLETED TOO FAST. THERE WAS NO REPORTED IMPACT TO THE CUSTOMER¿S BLOOD GLUCOSE LEVEL. CUSTOMER DECLINED FOLLOW-UP OR TO PROVIDE ADDITIONAL DETAILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24278648 ↗
• MalfunctionFeb 5, 2026Failure to Charge

  IT WAS REPORTED THAT THE PUMP BATTERY COULD NOT BE CHARGED. 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 24273388 ↗
• MalfunctionFeb 5, 2026Tactile Prompts/Feedback

  IT WAS REPORTED THAT THE PUMP WAS NOT VIBRATING WHEN ALERTS AND ALARMS WERE DECLARED. THERE WAS NO ADVERSE IMPACT TO THE CUSTOMER'S BLOOD GLUCOSE LEVEL. REPORTEDLY, THE CUSTOMER CONTINUED USING THE PUMP FOR INSULIN THERAPY UNTIL THE REPLACEMENT PUMP ARRIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24268646 ↗
• MalfunctionFeb 3, 2026Premature Discharge of Battery

  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 CONTINUED TO USE THE PUMP FOR INSULIN THERAPY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24251491 ↗
• MalfunctionJan 28, 2026Display or Visual Feedback Problem

  IT WAS REPORTED THAT THE PUMP TOUCHSCREEN WAS ON, BUT THE DISPLAY REMAINED BLACK. THE CUSTOMER REVERTED TO AN ALTERNATE METHOD OF INSULIN THERAPY. THERE WAS NO ADVERSE IMPACT TO THE CUSTOMER'S BLOOD GLUCOSE LEVEL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24202682 ↗
• MalfunctionJan 12, 2026Pumping Stopped

  CUSTOMER REPORTED AN ISSUE WITH THE PUMP INDICATING A CARTRIDGE ALARM 20, BUT THERE WAS NO ADVERSE IMPACT ON THE CUSTOMER¿S BLOOD GLUCOSE LEVEL. AS THE PUMP WAS OUT OF WARRANTY, TECHNICAL SUPPORT DECIDED TO REPLACE IT AND ADVISED THE CUSTOMER TO USE MDI AS BACKUP THERAPY. THE CUSTOMER WAS INFORMED THAT THEY WOULD RECEIVE A REPLACEMENT PUMP WITH UPDATED SOFTWARE AND INSTRUCTED TO PROGRAM THEIR SETTINGS AND CONNECT THEIR CGM TO THE NEW PUMP. CUSTOMER AGREED TO SEND INSURANCE CARD PICTURES, AND ARRANGEMENTS WERE MADE TO PROVIDE AN OUT-OF-WARRANTY LOANER PUMP UNTIL THE REPLACEMENT ARRIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24036752 ↗
• InjuryJan 12, 2026Mechanical Problem

  A CARTRIDGE ALARM WAS REPORTED BY THE CUSTOMER DURING THE LOAD PROCESS, WITH THE BLOOD GLUCOSE VALUE DISPLAYED AS "HIGH," ALTHOUGH THE SPECIFIC VALUE WAS UNKNOWN. THE CUSTOMER MANAGED THE HIGH BLOOD GLUCOSE BY ADMINISTERING A CORRECTION INJECTION USING A MULTIPLE DAILY INJECTION METHOD. THE CALLER WAS EDUCATED TO WAIT UNTIL PROMPTED DURING THE LOAD PROCESS TO REMOVE THE USED CARTRIDGE, WHICH THEY UNDERSTOOD AND ACKNOWLEDGED. TECHNICAL SUPPORT RESOLVED TO REPLACE THE PUMP, EVEN THOUGH IT WAS OUT OF WARRANTY, BUT THE CUSTOMER DECLINED THE OFFER FOR AN OUT-OF-WARRANTY LOANER PUMP.

  Patient problems: Hyperglycemia

  MAUDE report 24035874 ↗
• MalfunctionJan 8, 2026Pumping Stopped

  CALLER REPORTED THAT PUMP EXPERIENCED A MALFUNCTION. THERE WAS NO REPORTED IMPACT ON THE CUSTOMER'S BLOOD GLUCOSE LEVEL AS IT WAS UNCLEAR OR NOT PROVIDED. CUSTOMER RECEIVED ASSISTANCE FROM TECHNICAL SUPPORT TO RESET THE PUMP, AFTER WHICH THE MALFUNCTION DID NOT RECUR. CALLER WAS ADVISED TO CONTINUE USING THE PUMP AND TO CALL BACK IF ANY FURTHER MALFUNCTION CODES APPEARED, WHICH THEY ACKNOWLEDGED AND UNDERSTOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24012710 ↗
• InjuryJan 8, 2026Adverse Event Without Identified Device or Use Problem

  A CUSTOMER REPORTED EXPERIENCING HOSPITALIZATION DUE TO A SEIZURE CAUSED BY HYPOGLYCEMIA. THE CUSTOMER DECLINED FOLLOW-UP FROM TANDEM TECHNICAL SUPPORT REGARDING THE ISSUE, THEREFORE NO ADDITIONAL INFORMATION WAS OBTAINED.

  Patient problems: Convulsion/Seizure; Hypoglycemia

  MAUDE report 24003849 ↗
• MalfunctionJan 2, 2026Pumping Stopped

  IT WAS REPORTED THAT A MALFUNCTION ALARM OCCURRED. CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 435 MG/DL. DURING TROUBLESHOOTING WITH TECHNICAL SUPPORT, THE MALFUNCTION ALARM WAS CLEARED, AND INSULIN DELIVERY WAS RESUMED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23943704 ↗