BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 6053617 · Received October 25, 2016

    Report

    Report Number
    3007981285-2016-15973
    Event Type
    Malfunction
    Date Received
    October 25, 2016
    Date of Event
    October 2, 2016
    Report Date
    October 3, 2016
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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 ALTHOUGH THE PUMP WAS ABLE TO BEEP AND VIBRATE, IT WAS NOTED TO OTHERWISE BE UNRESPONSIVE AND STOPPED ALL INSULIN DELIVERY. THE CUSTOMER'S BLOOD GLUCOSE (BG) LEVEL WAS 187 (MG/DL). IT WAS INDICATED THAT THE CUSTOMER WOULD USE MANUAL INJECTIONS AS ALTERNATE INSULIN THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    704904 TANDEM T:SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG TANDEM DIABETES CARE 004628

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR