BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM G5 SYSTEM

    MDR report key: 10320323 · Received July 24, 2020

    Report

    Report Number
    3013756811-2020-76463
    Event Type
    Malfunction
    Date Received
    July 24, 2020
    Date of Event
    February 21, 2018
    Report Date
    July 24, 2020
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    OYC
    UDI-DI
    00853052007271
    PMA / PMN Number
    P140015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    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 WAS STICKING WHICH LED TO A BUTTON ALARM THAT COULD NOT BE CLEARED. IN ADDITION, WHEN THE PUMP WAS PLUGGED INTO A POWER SOURCE, THE PUMP WOULD GO INTO STORAGE MODE DUE TO THE WAKE BUTTON BEING STUCK DOWN. CUSTOMER¿S BLOOD GLUCOSE WAS 220-350 MG/DL. REPORTEDLY, THE CUSTOMER WILL CONTINUE TO USE CURRENT PUMP, AND HAS MANUAL INJECTIONS AVAILABLE FOR INSULIN THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    785738 T:SLIM G5 SYSTEM CONTINUOUS GLUCOSE MONITOR OYC TANDEM DIABETES CARE 1000096 00853052007271

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR