BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TANDEM T: SLIM INSULIN DELIVER SYSTEM

    MDR report key: 4105930 · Received September 18, 2014

    Report

    Report Number
    3007981285-2014-08510
    Event Type
    Injury
    Date Received
    September 18, 2014
    Date of Event
    September 7, 2014
    Report Date
    September 7, 2014
    Manufacturer
    TANDEM DIABETES CARE INC.
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT RETURNING FOR EVALUATION. SHOULD NEW INFORMATION 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 (170-350 MG/DL). CUSTOMER TOOK MANUAL INJECTIONS, AND CHANGED HER INFUSION SET AND CARTRIDGE TO STABILIZE HER BLOOD GLUCOSE LEVELS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    578778 TANDEM T: SLIM INSULIN DELIVER SYSTEM INSULIN PUMP LZG TANDEM DIABETES CARE INC. 004628

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Other