BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TANDEM T:SLIM INSULIN DELIVER SYSTEM

    MDR report key: 3972889 · Received April 28, 2014

    Report

    Report Number
    3007981285-2014-00438
    Event Type
    Malfunction
    Date Received
    April 28, 2014
    Date of Event
    March 28, 2014
    Report Date
    April 1, 2014
    Manufacturer
    TANDEM DIABETES CARE INC.
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SCREEN ON/QUICK BOLUS BUTTON ONLY FUNCTIONS TWO OUT OF THREE TIMES. IT SHOULD BE NOTED THAT THE PUMP HAS BEEN DROPPED IN THE PAST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    253626 TANDEM T:SLIM INSULIN DELIVER SYSTEM INSULIN PUMP LZG TANDEM DIABETES CARE INC. 004628

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR