BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T:SLIM G4 SYSTEM

    MDR report key: 6110901 · Received November 17, 2016

    Report

    Report Number
    3007981285-2016-20382
    Event Type
    Injury
    Date Received
    November 17, 2016
    Date of Event
    October 28, 2016
    Report Date
    October 29, 2016
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    OYC
    PMA / PMN Number
    P140015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, 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 WAKE BUTTON HAS STOPPED FUNCTIONING. IT WAS ALSO REPORTED THAT THE CUSTOMER RECEIVED MULTIPLE ONGOING OCCLUSION ALARMS. DURING TROUBLESHOOTING WITH TANDEM TECHNICAL SUPPORT, IT WAS CONFIRMED THAT THE PUMP STILL TURNS ON WHEN PLUGGED INTO A POWER SOURCE, AND THAT THERE WERE SMALL AIR BUBBLES IN THE PATIENT LINE. CUSTOMER REPORTED A BLOOD GLUCOSE LEVEL OF 449 (MG/DL) AT THE TIME OF THE CALL THAT WAS ADDRESSED WITH AN INSULIN PEN INJECTION. CUSTOMER REPORTED THAT THEY WOULD REVERT TO INSULIN INJECTIONS FOR ALTERNATE INSULIN THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    761253 T:SLIM G4 SYSTEM INSULIN PUMP OYC TANDEM DIABETES CARE 4628-003

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Other INFUSION SET, INSULIN: NOVOLOG