BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    MDR report key: 12933682 · Received December 6, 2021

    Report

    Report Number
    3013756811-2021-136213
    Event Type
    Malfunction
    Date Received
    December 6, 2021
    Date of Event
    November 5, 2021
    Report Date
    December 6, 2021
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    UDI-DI
    00850006613762
    PMA / PMN Number
    K201214
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    NO PRODUCT WAS RETURNED FOR EVALUATION. SHOULD NEW RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PER TANDEM¿S PUMP USER GUIDE: DO NOT REMOVE OR ADD INSULIN FROM A FILLED CARTRIDGE AFTER LOADING ONTO THE PUMP. THIS WILL RESULT IN AN INACCURATE DISPLAY OF THE INSULIN LEVEL ON THE HOME SCREEN AND YOU COULD RUN OUT OF INSULIN BEFORE THE PUMP DETECTS AN EMPTY CARTRIDGE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CARTRIDGE WAS LEAKING FROM THE SEPTUM. ADDITIONALLY, THE INSULIN GAUGE WAS INACCURATE. REPORTEDLY, THE CUSTOMER OVERFILLED THE CARTRIDGE. CUSTOMER DECLINED FURTHER TROUBLESHOOTING WITH TANDEM TECHNICAL SUPPORT. CUSTOMER¿S BLOOD GLUCOSE VALUE WAS BETWEEN 111-253 MG/DL

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1831194 T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY ALTERNATE CONTROLLER ENABLED INFUSION PUMP QFG TANDEM DIABETES CARE 1002717 00850006613762

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Female