BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TANDEM T:SLIM INSULIN DELIVER SYSTEM

    MDR report key: 3972892 · Received April 28, 2014

    Report

    Report Number
    3007981285-2014-00440
    Event Type
    Malfunction
    Date Received
    April 28, 2014
    Date of Event
    April 1, 2014
    Report Date
    April 1, 2014
    Manufacturer
    TANDEM DIABETES .
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SCREEN ON/QUICK BOLUS BUTTON HAS STOPPED FUNCTIONING AND THE PUMP WILL NOT TURN ON UNLESS PLUGGED INTO A POWER SOURCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    253720 TANDEM T:SLIM INSULIN DELIVER SYSTEM INSULIN PUMP LZG TANDEM DIABETES . 004628

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR