BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 6524903 · Received April 26, 2017

    Report

    Report Number
    3007981285-2017-11833
    Event Type
    Injury
    Date Received
    April 26, 2017
    Date of Event
    April 3, 2017
    Report Date
    April 26, 2017
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, 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 PUMP BATTERY DROPPED SUDDENLY MULTIPLE TIMES. THE CUSTOMER STATED THE BATTERY GAUGE DROPPED FROM 50% TO 20%. IN ADDITION, THE PUMP BATTERY WENT FROM 30% TO 95% QUICKLY. THE CUSTOMER'S BLOOD GLUCOSE (BG) LEVEL WAS 250-350 (MG/DL). CORRECTION BOLUSES WERE USED TO ADDRESS BG LEVEL. REPORTEDLY THE CUSTOMER WILL CONTINUE TO USE THE PUMP FOR INSULIN THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    302897 TANDEM T:SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG TANDEM DIABETES CARE 004628

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Other