BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM G5 SYSTEM

    MDR report key: 7074564 · Received December 1, 2017

    Report

    Report Number
    3007981285-2017-36588
    Event Type
    Malfunction
    Date Received
    December 1, 2017
    Date of Event
    September 29, 2017
    Report Date
    December 1, 2017
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    OYC
    PMA / PMN Number
    P140015
    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 PUMP BATTERY WAS OBSERVED TO BE DEPLETING QUICKLY. REVIEW OF THE PUMP HISTORY DURING TROUBLESHOOTING WITH TANDEM TECHNICAL SUPPORT SHOWED THE PUMP BATTERY FULLY DEPLETED FROM 80% AND THE PUMP SHUT OFF DUE TO INSUFFICIENT POWER WITHIN ONE DAY. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 160- 264 (MG/DL). REPORTEDLY THE CUSTOMER HAD MANUAL INJECTIONS AS ALTERNATE INSULIN THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    856632 T:SLIM G5 SYSTEM CONTINUOUS GLUCOSE MONITOR OYC TANDEM DIABETES CARE 1000096

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR