BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM G4 SYSTEM

    MDR report key: 6849411 · Received September 7, 2017

    Report

    Report Number
    3007981285-2017-25264
    Event Type
    Malfunction
    Date Received
    September 7, 2017
    Date of Event
    August 15, 2017
    Report Date
    September 7, 2017
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    OYC
    PMA / PMN Number
    P140015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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.

    Additional Manufacturer Narrative · 1

    THE FAILURE INVESTIGATION HAS BEEN COMPLETED AND THE ALLEGED CARTRIDGE ALARM 19 WAS VERIFIED. HOWEVER, BASED ON THE ANALYSIS, THE ALLEGED FILL ESTIMATE ISSUE COULD NOT BE VERIFIED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER RECEIVED AN INACCURATE FILL ESTIMATE AFTER LOADING A CARTRIDGE. REPORTEDLY, THE CARTRIDGE WAS FILLED WITH 200 UNITS OF INSULIN. ADDITIONALLY, THE CUSTOMER REPORTED RECEIVING A CARTRIDGE ALARM 19 DURING BASAL DELIVERY. THE CUSTOMER'S BLOOD GLUCOSE LEVEL RANGED FROM 180-192 (MG/DL). REPORTEDLY, THE CUSTOMER HAD MANUAL INJECTIONS AVAILABLE AS ALTERNATE INSULIN THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    627437 T:SLIM G4 SYSTEM INSULIN PUMP OYC TANDEM DIABETES CARE 4628-003

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR INSULIN: HUMALOG, INFUSION SET: T:90