BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    MDR report key: 19812108 · Received July 23, 2024

    Report

    Report Number
    3013756811-2024-122667
    Event Type
    Malfunction
    Date Received
    July 23, 2024
    Date of Event
    June 29, 2024
    Report Date
    August 16, 2024
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    UDI-DI
    00850006613793
    PMA / PMN Number
    K201214
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PER TANDEM'S USER GUIDE: YOUR T:SLIM X2 PUMP IS WATERTIGHT TO A DEPTH OF 3 FEET FOR UP TO 30 MINUTES (IPX7 RATING), BUT IT IS NOT WATERPROOF. THE DEVICE HAS BEEN RECEIVED FOR EVALUATION; HOWEVER, DEVICE EVALUATION IS NOT YET COMPLETE. A SUPPLEMENTAL REPORT WILL BE HTTPS://EMDR.FDA.GOV/EMDR/FORMREDACTION/B5.JSF#SUBMITTED UPON COMPLETION OF THE EVALUATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A MALFUNCTION ALARM OCCURRED. REPORTEDLY, THE PUMP WAS EXPOSED TO WATER. THE CUSTOMER REVERTED TO AN ALTERNATE METHOD OF INSULIN THERAPY. THERE WAS NO ADVERSE IMPACT TO THE CUSTOMER¿S BLOOD GLUCOSE LEVEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2482903 T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY ALTERNATE CONTROLLER ENABLED INFUSION PUMP QFG TANDEM DIABETES CARE 1000354 00850006613793

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Male