BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 3983391 · Received July 7, 2014

    Report

    Report Number
    3007981285-2014-02506
    Event Type
    Malfunction
    Date Received
    July 7, 2014
    Date of Event
    June 8, 2014
    Report Date
    June 8, 2014
    Manufacturer
    TANDEM DIABETES CARE INC.
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT YET BEEN RECEIVED FOR EVAL. SHOULD ADDITIONAL INFO BE RECEIVED, A SUPPLEMENTAL FORM WILL BE COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TOUCH SCREEN IS DISPLAYING YELLOW AND BLUE LINE ACROSS THE SCREEN. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS NOT IMPACTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    394907 TANDEM T:SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG TANDEM DIABETES CARE INC. 004628

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR