BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LOGIC BLOOD GLUCOSE MONITOR

    MDR report key: 1052309 · Received May 22, 2008

    Report

    Report Number
    3004193489-2008-00427
    Event Type
    Malfunction
    Date Received
    May 22, 2008
    Date of Event
    May 18, 2008
    Report Date
    May 22, 2008
    Manufacturer
    NOVA BIOMEDICAL CORP.
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    NOVA BIOMEDICAL AWAITS THE RETURN OF THE DEVICE FOR EVALUATION. SHOULD ANY SIGNIFICANT FINDINGS BE A RESULT OF THAT INVESTIGATION, A FOLLOW-UP REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO NOVA BIOMEDICAL THAT A CONSUMER RECEIVED A RESULT OF 471 MG/DL ON THEIR BLOOD GLUCOSE METER. THE CONSUMER IMMEDIATELY PERFORMED ANOTHER TEST USING THE SAME METER AND STRIPS GETTING A RESULT OF 447 MG/DL. THE CONSUMER OPENED A NEW VIAL OF NOVA TEST STRIPS DID ANOTHER TEST WITHIN A TEN MINUTE FRAME, GETTING A RESULT OF 183 MG/DL, WHICH THEY BELIEVED TO BE THE CORRECT RESULT. THE DIFFERENCE IN THE READINGS WAS DETERMINED TO BE CLINICALLY SIGNIFICANT. "THE TEST STRIPS IN QUESTION WILL BE RETURNED FOR."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BD LOGIC BLOOD GLUCOSE MONITOR GLUCOSE MONITOR NBW NOVA BIOMEDICAL CORP. NA 1020207253

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK