BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 3760961 · Received April 10, 2014

    Report

    Report Number
    3007981285-2014-00377
    Event Type
    Injury
    Date Received
    April 10, 2014
    Date of Event
    March 11, 2014
    Report Date
    March 12, 2014
    Manufacturer
    TANDEM DIABETES
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT HAS BEEN RETURNED FOR EVALUATION. SHOULD NEW INFO BECOME AVAILABLE, A F/U MDR WILL BE SUBMITTED. T:SLIM USER GUIDE INDICATES, PUMP IS TO BE USED WITH INDIVIDUALS 12 YEARS OF AGE AND GREATER, PATIENT IS (B)(6) YEARS AGO.

    Description of Event or Problem · 1

    REC'D INFO STATING PATIENT HAD A VIRAL INFECTION THAT CAUSED HIGH BG'S AND CULMINATED TO DKA. PATIENT WAS TREATED WITH IV FLUIDS AND INSULIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    216157 TANDEM T:SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG TANDEM DIABETES 004628

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR Hospitalization| R