BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TANDEM TSLIM X2

    MDR report key: 23276089 · Received October 14, 2025

    Report

    Report Number
    MW5177205
    Event Type
    Injury
    Date Received
    October 14, 2025
    Report Date
    October 9, 2025
    Manufacturer
    TANDEM DIABETES CARE, INC.
    Product Code
    QFG
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    MY TANDEM INSULIN PUMPS HAVE NOT BEEN WORKING SINCE I UPDATED TO CONTROL IQ. I NEED TO CHARGE MULTIPLE TIMES A DAY EVERYDAY; THEY WILL RANDOMLY COMPLETELY DISCHARGE THEIR BATTERY. I HAVE RECEIVED MULTIPLE REPLACEMENTS. I THINK I'M ON NUMBER SIX OR SEVEN IN THE LAST COUPLE OF MONTHS, NOT A SINGLE ONE OF THEM HAS WORKED FOR MORE THAN A WEEK OR TWO. EVERY TIME THAT I CALL ABOUT THE ISSUE I GET SENT A REFURBISHED PUMP. THEY REFUSED TO SEND ME A NEW REPLACEMENT EVEN THOUGH MY PUMP WAS ALMOST BRAND NEW WHEN I STARTED HAVING THE ISSUES. THE MOST RECENT PUMP FAILURE THE PUMP WON'T EVEN TURN BACK ON AT ALL AND IT WAS AGAIN DISCHARGING THE BATTERY COMPLETELY AND UNEXPECTEDLY. I HAVE BEEN SLEEPING WITH MY PUMP PLUGGED IN TO A CORD. THIS IS NOT SUSTAINABLE AND WILL NOT WORK WHEN I'M TRAVELING. PRIOR TO CONTROL IQ, MY PUMP WAS ABLE TO HOLD A BATTERY FOR A DAY OR UP TO 3 DAYS. REFERENCE REPORT# MW5177200, MW5177201, MW5177202, MW5177203, MW5177204.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    179447 TANDEM TSLIM X2 ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP QFG TANDEM DIABETES CARE, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Female Other