BEUDAMED
    FDA Adverse Event Other Summary report: N

    NOVAMAX LINK GLUCOSE MONITOR

    MDR report key: 3919529 · Received June 17, 2014

    Report

    Report Number
    3004193489-2014-00046
    Event Type
    Other
    Date Received
    June 17, 2014
    Date of Event
    June 3, 2014
    Report Date
    June 3, 2014
    Manufacturer
    NOVA BIOMEDICAL CORPORATION
    Product Code
    NBW
    PMA / PMN Number
    K040603
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    TEST STRIP LOT #: UNK.

    Description of Event or Problem · 1

    IT WAS REPORTED TO NOVA BIOMEDICAL THAT THE CONSUMER WAS "ADMITTED TO THE HOSP AFTER FEELING VERY SICK AND BELIEVED SHE HAD BEEN RECEIVING INACCURATE BLOOD GLUCOSE RESULTS." THE RESULTS OBTAINED AT HOME WERE VERY HIGH AND HER SYMPTOMS WERE OF HYPERGLYCEMIA. UPON ARRIVAL AT THE HOSP, HER DIAGNOSIS WAS OF HYPERGLYCEMIA AND DKA. THE CONSUMER WAS HOSPITALIZED AND TREATED. THE NOVA BIOMEDICAL EQUIPMENT APPEARED TO HAVE PERFORMED AS INTENDED. THIS IS BEING REPORTED AS AN ADVERSE EVENT UNDER THE FDA MEDWATCH REGULATIONS. ALL PRODUCTS WERE REQUESTED BACK FOR EVAL DUE TO THE ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    355635 NOVAMAX LINK GLUCOSE MONITOR GLUCOSE MONITOR NBW NOVA BIOMEDICAL CORPORATION NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization| R