BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM G4 SYSTEM

    MDR report key: 6141158 · Received December 2, 2016

    Report

    Report Number
    3007981285-2016-22461
    Event Type
    Malfunction
    Date Received
    December 2, 2016
    Date of Event
    November 12, 2016
    Report Date
    November 12, 2016
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    OYC
    PMA / PMN Number
    P140015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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 CUSTOMER RECEIVED MULTIPLE CARTRIDGE ALARMS (CARTRIDGE ALARM 19) WITH MULTIPLE CARTRIDGES DURING THE LOAD PROCESS. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 126 MG/DL. REPORTEDLY, THE CUSTOMER INDICATED INSULIN THERAPY WOULD BE OBTAINED. AN ATTEMPT WAS MADE TO FOLLOW UP; HOWEVER, THE CUSTOMER DID NOT RESPOND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    791469 T:SLIM G4 SYSTEM INSULIN PUMP OYC TANDEM DIABETES CARE 4628-003

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR