BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 9601511 · Received January 17, 2020

    Report

    Report Number
    3013756811-2020-08612
    Event Type
    Malfunction
    Date Received
    January 17, 2020
    Date of Event
    December 19, 2019
    Report Date
    January 17, 2020
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    LZG
    UDI-DI
    00852162004538
    PMA / PMN Number
    K111210
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WAS RETURNED FOR EVALUATION. SHOULD NEW RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE WAKE BUTTON WAS UNRESPONSIVE. CUSTOMER CONFIRMED PUMP DISPLAY TURNED ON WHEN PLUGGED INTO A POWER SOURCE. CUSTOMER¿S BLOOD GLUCOSE WAS 100-135 MG/DL. REPORTEDLY, CUSTOMER CONTINUED TO USE THE PUMP FOR INSULIN THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    62997 TANDEM T:SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG TANDEM DIABETES CARE 004628 00852162004538

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR