BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM G5 SYSTEM

    MDR report key: 8764730 · Received July 5, 2019

    Report

    Report Number
    3013756811-2019-39688
    Event Type
    Malfunction
    Date Received
    July 5, 2019
    Date of Event
    May 15, 2019
    Report Date
    July 5, 2019
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    OYC
    UDI-DI
    00853052007318
    PMA / PMN Number
    P140015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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 PUMP BATTERY WAS INTERMITTENTLY OBSERVED TO BE DEPLETING RAPIDLY. THERE WAS NO IMPACT TO THE CUSTOMER'S BLOOD GLUCOSE LEVEL. REPORTEDLY, THE CUSTOMER CONTINUED TO USE THEIR PUMP FOR INSULIN THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    558818 T:SLIM G5 SYSTEM CONTINUOUS GLUCOSE MONITOR OYC TANDEM DIABETES CARE 1000096 00853052007318

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR