BEUDAMED
    FDA Adverse Event Other Summary report: N

    BD PARADIGM LINK GLUCOSE MONITOR

    MDR report key: 1220247 · Received October 31, 2008

    Report

    Report Number
    3004193489-2008-00607
    Event Type
    Other
    Date Received
    October 31, 2008
    Date of Event
    October 24, 2008
    Report Date
    October 31, 2008
    Manufacturer
    NOVA BIOMEDICAL CORP.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 F/U REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO NOVA BIOMEDICAL THAT A CONSUMER RECEIVED A RESULT OF 285 MG/DL ON THEIR BLOOD GLUCOSE METER. CONTRARY TO THE HIGH RESULTS, THE CONSUMER EXPERIENCED A HYPOGLYCEMIC EVENT, WHICH DID NOT REQUIRE MEDICAL INTERVENTION. THE CONSUMER TREATED HIMSELF WITH CONSUMING ORANGE JUICE. DURING THE CALL, IT WAS REVEALED THAT THE CONSUMER IMPROPERLY STORES THEIR METER. IT WAS ALSO REVEALED AT THE TIME OF THE CALL, THAT THE CONSUMER DOES NOT CONTROL SOLUTION TEST BEFORE USE THEIR INITIAL TEST STRIPS, AS INSTRUCTED IN OUR DIRECTIONS FOR USE. THE CONSUMER WAS EDUCATED ON THESE DIRECTIONS FOR USE 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 CORP. NA 1020208057

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK