BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 3940228 · Received June 20, 2014

    Report

    Report Number
    3007981285-2014-02162
    Event Type
    Injury
    Date Received
    June 20, 2014
    Date of Event
    May 24, 2014
    Report Date
    May 24, 2014
    Manufacturer
    TANDEM DIABETES CARE INC.
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    LAY USER/PATIENT

    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). THE DEVICE HAS NOT BEEN RETURNED FOR EVAL. SHOULD NEW INFO BECOME AVAILABLE A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER HAS BEEN EXPERIENCING HIGH BG LEVELS (524 MG/DL), KETONES, AND SKIN IRRITATION AT INFUSION SITE FOR THE PAST 2 WEEKS RESULTING IN HOSPITALIZATION. THE CUSTOMER WAS RELEASED FROM THE HOSP ON (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    362572 TANDEM T:SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG TANDEM DIABETES CARE INC. 004628 M002603

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR Hospitalization| R