BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BGSTAR BGMS

    MDR report key: 2548493 · Received April 17, 2012

    Report

    Report Number
    3004637226-2012-00008
    Event Type
    Malfunction
    Date Received
    April 17, 2012
    Date of Event
    December 5, 2011
    Report Date
    April 16, 2012
    Manufacturer
    AGAMATRIX, INC.
    Product Code
    NBW
    PMA / PMN Number
    K072413
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    METER S/N (B)(4) AND TEST STRIP LOT # HL19WY28A, EXP: 05.2012 WITH RANGE 111-168 MG/DL WERE TESTED ON (B)(6) 2011. PERFORM,ANCE RESULTS AS FOLLOWS: 138 MG/DL, 139 MG/DL, AND 156 MG/DL. THE COMPLAINT COULD NOT BE CONFIRMED. THE FUNCTION TEST SHOWED THE BGSTAR METER WORKED PROPERLY AND MET SPECIFICATIONS.

    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.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other