BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM G4 SYSTEM

    MDR report key: 6155762 · Received December 8, 2016

    Report

    Report Number
    3007981285-2016-23765
    Event Type
    Malfunction
    Date Received
    December 8, 2016
    Date of Event
    November 17, 2016
    Report Date
    November 17, 2016
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    OYC
    PMA / PMN Number
    P140015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 MULTIPLE INTERMITTENT MALFUNCTION ALARMS OCCURRED AND THE PUMP STOPPED ALL INSULIN DELIVERY. CUSTOMER REPORTED A BLOOD GLUCOSE LEVEL BETWEEN 140-210 (MG/DL). IT WAS REPORTED THAT THE CUSTOMER HAD MANUAL INJECTIONS AVAILABLE FOR ALTERNATE INSULIN THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    806821 T:SLIM G4 SYSTEM INSULIN PUMP OYC TANDEM DIABETES CARE 4628-003

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR