BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TANDEM T: SLIM INSULIN DELIVERY SYS

    MDR report key: 3952560 · Received May 15, 2014

    Report

    Report Number
    3007981285-2014-00649
    Event Type
    Malfunction
    Date Received
    May 15, 2014
    Date of Event
    April 17, 2014
    Report Date
    April 17, 2014
    Manufacturer
    TANDEM DIABETES
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RECEIVED FOR EVALUATION; HOWEVER, EVALUATION IS NOT YET COMPLETE. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TOUCH SCREEN ARE UNRESPONSIVE EVEN WHEN PLUGGED INTO A POWER SOURCE. THE CUSTOMER ALSO REPORTS THAT ONLY THE TOP HALF OF THE SCREEN DISPLAYS NORMALLY AND THERE ARE CRACKS ON THE SCREEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290833 TANDEM T: SLIM INSULIN DELIVERY SYS INSULIN PUMP LZG TANDEM DIABETES 004628

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR