BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM G5 SYSTEM

    MDR report key: 8724850 · Received June 21, 2019

    Report

    Report Number
    3013756811-2019-34957
    Event Type
    Malfunction
    Date Received
    June 21, 2019
    Date of Event
    May 29, 2019
    Report Date
    June 21, 2019
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    OYC
    UDI-DI
    00853052007295
    PMA / PMN Number
    P140015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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 MULTIPLE CARTRIDGE ALARMS (ALARM 30) OCCURRED WITH MULTIPLE CARTRIDGES DURING BASAL DELIVERY. BLOOD GLUCOSE WAS BETWEEN 134-160 MG/DL. REPORTEDLY THE CUSTOMER CONTINUED TO USE THE PUMP FOR INSULIN THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    517820 T:SLIM G5 SYSTEM CONTINUOUS GLUCOSE MONITOR OYC TANDEM DIABETES CARE 1000096 00853052007295

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR