BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IBGSTAR BGMS

    MDR report key: 2576185 · Received May 10, 2012

    Report

    Report Number
    3004637226-2012-00025
    Event Type
    Malfunction
    Date Received
    May 10, 2012
    Date of Event
    April 12, 2012
    Report Date
    May 10, 2012
    Manufacturer
    AGAMATRIX, INC.
    Product Code
    NBW
    PMA / PMN Number
    K103544
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    METER WAS RETURNED AND TESTED PER MANUFACTURERS SPECIFICATIONS. NO FAULT FOUND WITH METER. PT WAS NOT HOSPITALIZED. THIS CASE HAS BEEN CLOSED.

    Description of Event or Problem · 1

    PT REPORTED HIGH VALUES VS ANOTHER METER. PT EXPERIENCED SYMPTOMS OF HYPOGLYCEMIA. IBGSTAR METER VALUE OF 13.9 MMOL/L, OTHER METER 11.1 MMOL/L; IBGSTAR METER VALUE OF 10.9 MMOL/L, OTHER METER 8.3 MMOL/L.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IBGSTAR BGMS BLOOD GLUCOSE METER NBW AGAMATRIX, INC. 8000-05723 HN30WB07C

    Patients

    Seq Age Sex Outcome Treatment
    1