BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BGSTAR BGMS

    MDR report key: 2548494 · Received April 17, 2012

    Report

    Report Number
    3004637226-2012-00010
    Event Type
    Malfunction
    Date Received
    April 17, 2012
    Date of Event
    December 15, 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 # IJ14WC13C, EXP: 11.2012 WITH RANGE 6.0 - 9.0 MMOL/L WERE TESTED ON (B)(6) 2012. PERFORMANCE RESULTS AS FOLLOWS: 8.6 MMOL/L, 8.5 MMOL/L, AND 8.5 MMOL/L. THE COMPLAINT COULD NOT BE CONFIRMED. THE FUNCTION TEST SHOWED THE BG STAR 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. 8000-05000

    Patients

    Seq Age Sex Outcome Treatment
    1 Other