BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TANDEM T: SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 3905048 · Received May 27, 2014

    Report

    Report Number
    3007981285-2014-00807
    Event Type
    Malfunction
    Date Received
    May 27, 2014
    Date of Event
    April 24, 2014
    Report Date
    April 24, 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

    Additional Manufacturer Narrative · 1

    T: SLIM USER GUIDE STATES: T: SLIM USER GUIDE INDICATES, PUMP IS TO BE USED WITH INDIVIDUALS 12 YEARS OF AGE AND GREATER, PATIENT IS (B)(6).

    Description of Event or Problem · 1

    RECEIVED INFORMATION ALLEGING PATIENT HAS EXPERIENCED FLUCTUATING BG'S. AS PER REPORTER THEY ARE CONFIDENT ISSUE IS NOT PUMP RELATED BUT A SETTINGS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    312092 TANDEM T: SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG TANDEM DIABETES 004628

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR