BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 6116706 · Received November 21, 2016

    Report

    Report Number
    3007981285-2016-22069
    Event Type
    Malfunction
    Date Received
    November 21, 2016
    Date of Event
    October 1, 2016
    Report Date
    November 4, 2016
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, 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 CUSTOMER EXPERIENCED INTERMITTENT DIFFICULTY WITH CHARGING THE PUMP OVER THE PAST FEW MONTHS. THERE WAS NO REPORTED IMPACT TO THE CUSTOMER'S BLOOD GLUCOSE LEVELS. CONTACT REPORTED THAT THEY HAVE BEEN ABLE TO RECONNECT AND CHARGE THE PUMP SUCCESSFULLY. CONTACT STATED THAT THE CUSTOMER WILL CONTINUE TO USE THE PUMP FOR INSULIN THERAPY, AND HAVE INSULIN INJECTIONS FOR ALTERNATE INSULIN THERAPY IF NEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    769336 TANDEM T:SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG TANDEM DIABETES CARE 004628

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR