BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BGSTAR BGMS

    MDR report key: 2548492 · Received April 17, 2012

    Report

    Report Number
    3004637226-2012-00007
    Event Type
    Malfunction
    Date Received
    April 17, 2012
    Date of Event
    October 28, 2011
    Report Date
    April 16, 2012
    Manufacturer
    AGAMATRIX, INC.
    Product Code
    NBW
    PMA / PMN Number
    K072413
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION NOT POSSIBLE- PATIENT THREW DEVICE AWAY.

    Description of Event or Problem · 1

    AN EVENT OCCURRED WITH THE BGSTAR SYSTEM WHERE INDIRECT HARM OCCURRED BECAUSE THE PATIENT INJECTED A HIGHER INSULIN DOSE AND WENT INTO HYPOGLYCEMIA BASED ON READINGS ON THE BGSTAR WHICH WERE PRESUMED TO BE TOO HIGH. PATIENT THREW DEVICE AWAY. NO INVESTIGATION POSSIBLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BGSTAR BGMS BLOOD GLUCOSE METER NBW AGAMATRIX, INC. 8000-05000/04992

    Patients

    Seq Age Sex Outcome Treatment
    1 Other