BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TANDEM T: SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 3925510 · Received June 18, 2014

    Report

    Report Number
    3007981285-2014-02106
    Event Type
    Injury
    Date Received
    June 18, 2014
    Date of Event
    May 19, 2014
    Report Date
    May 19, 2014
    Manufacturer
    TANDEM DIABETES CARE INC.
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. SHOULD NEW INFORMATION BECOME AVAILABLE A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER IS EXPERIENCING HIGH BGS POSSIBLE DUE TO HER PERSONAL PROFILE SETTINGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    356773 TANDEM T: SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG TANDEM DIABETES CARE INC. 004628

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Other