BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IBGSTAR BGMS

    MDR report key: 2824614 · Received October 25, 2012

    Report

    Report Number
    3004637226-2012-00038
    Event Type
    Malfunction
    Date Received
    October 25, 2012
    Date of Event
    September 5, 2012
    Report Date
    October 23, 2012
    Manufacturer
    AGAMATRIX, INC.
    Product Code
    NBW
    PMA / PMN Number
    K103544
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    METER WAS NOT RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    IBGSTAR METER INDICATED BLOOD GLUCOSE LEVEL OF 125 MG/ DL. PATIENT INJECTED 5 IU OF RAPID INSULIN (HUMALOG). SHORTLY AFTER SHE BECAME HYPOGLYCEMIC. THERE WAS NO LOSS OF CONSCIOUSNESS, NO SEIZURES. HER HUSBAND MADE A MEASUREMENT WITH IBGSTAR AND VALUE WAS 57 MG/ DL. (B)(6) WAS CALLED AND THE PATIENT WAS TRANSFERRED TO HOSPITAL. SHE WAS DISCHARGED THE FOLLOWING DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IBGSTAR BGMS BLOOD BLUCOSE METER NBW AGAMATRIX, INC. 8000-05716

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR