BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IBGSTAR BGMS

    MDR report key: 2576189 · Received May 10, 2012

    Report

    Report Number
    3004637226-2012-00024
    Event Type
    Malfunction
    Date Received
    May 10, 2012
    Date of Event
    April 11, 2012
    Report Date
    May 10, 2012
    Manufacturer
    AGAMATRIX, INC.
    Product Code
    NBW
    PMA / PMN Number
    K103544
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    METER WAS NOT RETURNED TO MANUFACTURER FOR EVALUATION. PT WAS NOT HOSPITALIZED. AN UPDATED REPORT WILL BE SUBMITTED IF ADDITIONAL INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    PT REPORTED HIGH VALUES VS ANOTHER METER. PT EXPERIENCED SYMPTOMS OF HYPOGLYCEMIA: IBGSTAR METER GAVE GLUCOSE VALUE OF 150 MG/DL AND 120 MG/DL 15 MINUTES LATER. SIMULTANEOUS TEST WITH PAPILLON INSULIX METER GAVE 40 MG/DL.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other