BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T:FLEX INSULIN DELIVERY SYSTEM

    MDR report key: 6094469 · Received November 10, 2016

    Report

    Report Number
    3007981285-2016-18921
    Event Type
    Injury
    Date Received
    November 10, 2016
    Date of Event
    October 22, 2016
    Report Date
    October 22, 2016
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    LZG
    PMA / PMN Number
    K143189
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    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 · 1

    IT WAS REPORTED THAT THE WAKE BUTTON HAS STOPPED FUNCTIONING. DURING TROUBLESHOOTING WITH TANDEM TECHNICAL SUPPORT, IT WAS CONFIRMED THAT THE PUMP STILL TURNS ON WHEN PLUGGED INTO A POWER SOURCE. CONTACT REPORTED THAT THE CUSTOMER HAD A BLOOD GLUCOSE LEVEL OF 300 (MG/DL) THAT WAS ADDRESSED WITH INSULIN INJECTIONS. REPORTEDLY, CUSTOMER WILL CONTINUE TO REVERT TO INJECTIONS FOR ALTERNATE INSULIN THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    743195 T:FLEX INSULIN DELIVERY SYSTEM INFUSION PUMP LZG TANDEM DIABETES CARE 004628-005

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Other