BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    MDR report key: 15563050 · Received October 7, 2022

    Report

    Report Number
    3013756811-2022-112599
    Event Type
    Malfunction
    Date Received
    October 7, 2022
    Date of Event
    September 15, 2022
    Report Date
    November 18, 2022
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    UDI-DI
    00850006613779
    PMA / PMN Number
    K201214
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HAS BEEN RECEIVED FOR EVALUATION; HOWEVER, DEVICE EVALUATION IS NOT YET COMPLETE. A SUPPLEMENTAL REPORT WILL BE FILED UPON COMPLETION OF THE EVALUATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PUMP BATTERY COULD NOT BE CHARGED, AND SUBSEQUENTLY THE PUMP SHUTDOWN. CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 200-245 MG/DL. AT THE TIME OF THE CALL WITH TANDEM TECHNICAL SUPPORT THE CUSTOMER DID NOT HAVE AN ALTERNATE METHOD FOR INSULIN THERAPY. THE CUSTOMER DECLINED FURTHER FOLLOW UP FROM TANDEM TECHNICAL SUPPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2554771 T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY ALTERNATE CONTROLLER ENABLED INFUSION PUMP QFG TANDEM DIABETES CARE 1002717 00850006613779

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Female