BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TANDEM T: SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 3883766 · Received June 10, 2014

    Report

    Report Number
    3007981285-2014-01055
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    May 5, 2014
    Report Date
    May 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
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT 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 EXPERIENCED HIGH BLOOD GLUCOSE LEVELS (555 MG/DL), RESULTING IN THE CUSTOMER BEING HOSPITALIZED. WHEN THE INFUSION SET TUBING WAS REMOVED, THE TUBING WAS BLOODY. THE CUSTOMER HAD DEHYDRATION AND LOW MAGNESIUM LEVELS. CUSTOMER WAS RELEASED FROM THE HOSPITAL WITH LOWER BGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343443 TANDEM T: SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG TANDEM DIABETES 004628 M001825

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Hospitalization