BEUDAMED
    FDA Adverse Event Other Summary report: N

    BD PARADIGM LINK GLUCOSE MONITOR

    MDR report key: 1375619 · Received February 27, 2009

    Report

    Report Number
    3004193489-2009-00029
    Event Type
    Other
    Date Received
    February 27, 2009
    Date of Event
    February 12, 2009
    Report Date
    February 27, 2009
    Manufacturer
    NOVA BIOMEDICAL CORPORATION
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    NOVA BIOMEDICAL AWAITS THE RETURN OF THE DEVICE FOR EVALUATION. SHOULD ANY SIGNIFICANT FINDING 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 EXPERIENCED A HYPOGLYCEMIC EVENT WHICH DID NOT REQUIRE MEDICAL INTERVENTION. DURING THE CALL, IT WAS REVEALED THAT THE CONSUMER'S BLOOD GLUCOSE METER WAS NOT PROPERLY CODED TO THE TEST STRIPS AND THE CONSUMER DOES NOT CONTROL SOLUTION TEST THEIR TEST STRIPS BEFORE USE AS INSTRUCTED IN OUR DIRECTIONS FOR USE. EDUCATION TOOK PLACE AT THE TIME OF CALL. THE METER IN QUESTION WILL BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BD PARADIGM LINK GLUCOSE MONITOR GLUCOSE MONITOR NBW NOVA BIOMEDICAL CORPORATION NA 1020208128

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK