BEUDAMED
    FDA Adverse Event Other Summary report: N

    BD PARADIGM LINK GLUCOSE MONITOR

    MDR report key: 1200374 · Received October 10, 2008

    Report

    Report Number
    3004193489-2008-00589
    Event Type
    Other
    Date Received
    October 10, 2008
    Date of Event
    October 2, 2008
    Report Date
    October 10, 2008
    Manufacturer
    NOVA BIOMEDICAL CORPORATION
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, 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 HIGH BLOOD GLUCOSE READING. NO REPORTED TREATMENT WAS ADMINISTERED YET HE SUBSEQUENTLY EXPERIENCED A HYPOGLYCEMIC EVENT REQUIRING MEDICAL INTERVENTION. DURING THE CALL, IT WAS REVEALED THAT THE CONSUMER STORES LOOSE TEST STRIPS IN THE TRUNK OF HIS CAR AND DOES NOT PERFORM REGULAR CONTROL SOLUTION TESTS ON NEW VIALS OF TEST STRIPS AS DIRECTED IN OUR DIRECTIONS FOR USE. THESE PRACTICES CANNOT ENSURE THE INTEGRITY OF THE TEST STRIPS. THE CONSUMER HAS BEEN REQUESTED TO SEND BACK TEST STRIPS AND BLOOD GLUCOSE METER 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 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention