BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TANDEM T:SLIM INSULIN DELIVERY SYS

    MDR report key: 3915480 · Received June 5, 2014

    Report

    Report Number
    3007981285-2014-00993
    Event Type
    Malfunction
    Date Received
    June 5, 2014
    Date of Event
    May 7, 2014
    Report Date
    May 10, 2014
    Manufacturer
    TANDEM DIABETES
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    T: SLIM USER GUIDE INDICATES, PUMP IS TO BE USED WITH INDIVIDUALS 12 YEARS OF AGE AND GREATER, PT IS (B)(6) YEARS OLD. THE PRODUCT HAS NOT BEEN RETURNED FOR EVALUATION. SHOULD NEW INFO BECOME AVAILABLE A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SCREEN ON/QUICK BOLUS BUTTON HAS STOPPED FUNCTIONING AND THE PUMP ONLY WORKS WHEN PLUGGED INTO A POWER SOURCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    328855 TANDEM T:SLIM INSULIN DELIVERY SYS INSULIN PUMP LZG TANDEM DIABETES 004628

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR