BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:FLEX INSULIN DELIVERY SYSTEM

    MDR report key: 5980903 · Received September 27, 2016

    Report

    Report Number
    3007981285-2016-11767
    Event Type
    Malfunction
    Date Received
    September 27, 2016
    Date of Event
    September 8, 2016
    Report Date
    September 8, 2016
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    LZG
    PMA / PMN Number
    K143189
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS EXPECTED TO BE RETURNED; HOWEVER, THE DEVICE HAS NOT YET BEEN RECEIVED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF THE DEVICE IS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A MALFUNCTION ALARM OCCURRED AND THE PUMP STOPPED ALL INSULIN DELIVERY. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS NOT IMPACTED. IT WAS CONFIRMED THAT THE CUSTOMER HAD A BACKUP METHOD OF INSULIN DELIVERY AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    631200 T:FLEX INSULIN DELIVERY SYSTEM INFUSION PUMP LZG TANDEM DIABETES CARE 004628-005

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR