BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IBGSTAR BGMS

    MDR report key: 2548593 · Received April 17, 2012

    Report

    Report Number
    3004637226-2012-00020
    Event Type
    Malfunction
    Date Received
    April 17, 2012
    Date of Event
    March 29, 2012
    Report Date
    April 16, 2012
    Manufacturer
    AGAMATRIX, INC.
    Product Code
    NBW
    PMA / PMN Number
    K103544
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    METER REQUESTED FROM CUSTOMER. REPORT WILL BE UPDATED IF ADD'L INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    PT REPORTED HIGH VALUES VS ANOTHER METER. IBGSTAR METER GAVE GLUCOSE VALUE OF 255 MG/DL, PT INJECTED 2.5UI OF INSULIN AND BLOOD GLUCOSE VALUE WAS SUDDENLY REDUCED TO 47 MG/DL WHEN IT SHOULD HAVE BEEN 100 MG/DL. PT WAS NOT HOSPITALIZED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IBGSTAR BGMS BLOOD GLUCOSE MITER NBW AGAMATRIX, INC. 8000-05702 HT19WZ08C

    Patients

    Seq Age Sex Outcome Treatment
    1 Other