BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM G5 SYSTEM

    MDR report key: 8724650 · Received June 21, 2019

    Report

    Report Number
    3013756811-2019-34171
    Event Type
    Malfunction
    Date Received
    June 21, 2019
    Date of Event
    May 30, 2019
    Report Date
    June 21, 2019
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    OYC
    UDI-DI
    00853052007257
    PMA / PMN Number
    P140015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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.

    Additional Manufacturer Narrative · 1

    THE FAILURE INVESTIGATION HAS BEEN COMPLETED AND THE ALLEGED ALARM 30 ISSUE WAS VERIFIED. ADDITIONALLY, THE ALLEGED WAKE BUTTON ISSUE COULD NOT BE VERIFIED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER RECEIVED A BUTTON ALARM. REPORTEDLY, THERE WAS NOTHING PRESSING THE BUTTON. ADDITIONALLY, CARTRIDGE ALARM 30 OCCURRED DURING BASAL DELIVERY WITH MULTIPLE CARTRIDGES. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS BETWEEN 150-325 MG/DL. REPORTEDLY, THE CUSTOMER REVERTED TO MANUAL INJECTIONS FOR ALTERNATE INSULIN THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    518315 T:SLIM G5 SYSTEM CONTINUOUS GLUCOSE MONITOR OYC TANDEM DIABETES CARE 1000096 00853052007257

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR