BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TANDEM T:SLIM X2 INFUSION INSULIN PUMP

    MDR report key: 21677695 · Received March 24, 2025

    Report

    Report Number
    MW5168029
    Event Type
    Injury
    Date Received
    March 24, 2025
    Date of Event
    March 13, 2025
    Report Date
    March 17, 2025
    Manufacturer
    TANDEM DIABETES CARE, INC.
    Product Code
    QFG
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED ON 4/9/2025 FOR REPORT MW5168029 TO UPDATE PROCODE TO QFG.

    Description of Event or Problem · 0

    RECEIVED A CALL END OF DECEMBER 24 TO UPDATE FIRMWARE ON MY TSLIM PUMP. UPDATED FIRMWARE PER TANDEM'S REQUEST. BATTERY NOW DIES VERY QUICKLY. PUMP DIED OVERNIGHT, DIDN'T REALIZE IT WAS DEAD/OFF, RESULTING IN NO INSULIN FOR 24 HOURS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1718872 TANDEM T:SLIM X2 INFUSION INSULIN PUMP ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP QFG TANDEM DIABETES CARE, INC. 001000354

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Male Other| L INSULIN ASPART.