BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 4101148 · Received September 17, 2014

    Report

    Report Number
    3007981285-2014-08507
    Event Type
    Injury
    Date Received
    September 17, 2014
    Date of Event
    September 1, 2014
    Report Date
    September 5, 2014
    Manufacturer
    TANDEM DIABETES CARE INC.
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT RETURNING FOR EVAL. SHOULD NEW INFO BECOME AVAILABLE, A SUPPLEMENTAL FORM WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER HAS BEEN EXPERIENCING HIGH BLOOD GLUCOSE LEVELS (250 MG/DL). CUSTOMER HAS RECENTLY CHANGED HIS BASAL SETTINGS WITHOUT CONSULTING HIS HEALTH CARE PROFESSIONAL. HE TOOK A CORRECTION BOLUS TO STABILIZE HIS BLOOD GLUCOSE LEVELS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    576819 TANDEM T:SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG TANDEM DIABETES CARE INC. 004628

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Other