BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM G4 SYSTEM

    MDR report key: 6085088 · Received November 8, 2016

    Report

    Report Number
    3007981285-2016-18494
    Event Type
    Malfunction
    Date Received
    November 8, 2016
    Date of Event
    October 7, 2016
    Report Date
    October 17, 2016
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    OYC
    PMA / PMN Number
    P140015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WAS RETURNED FOR EVALUATION. SHOULD NEW RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER RECEIVED A CARTRIDGE ALARM 19 DURING THE LOAD PROCESS. REPORTEDLY, CUSTOMER WAS ABLE TO SUCCESSFULLY LOAD A NEW CARTRIDGE ONTO THE PUMP. THERE WAS NO REPORTED IMPACT TO CUSTOMER'S BLOOD GLUCOSE LEVEL. CUSTOMER STATED THAT THEY DID NOT RECALL THEIR BLOOD GLUCOSE LEVEL AT THE TIME OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    737090 T:SLIM G4 SYSTEM INSULIN PUMP OYC TANDEM DIABETES CARE 4628-003

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR