BEUDAMED
    FDA Adverse Event Other Summary report: N

    BD PARADIGM LINK GLUCOSE MONITOR

    MDR report key: 1821640 · Received August 26, 2010

    Report

    Report Number
    3004193489-2010-00185
    Event Type
    Other
    Date Received
    August 26, 2010
    Date of Event
    August 12, 2010
    Report Date
    August 26, 2010
    Manufacturer
    NOVA BIOMEDICAL CORP.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    NOVA BIOMEDICAL AWAITS THE RETURN OF THE DEVICE FOR EVAL. 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 CONTINUED TO ADMINISTER INSULIN BASED ON MULTIPLE HIGH READINGS ON THEIR BLOOD GLUCOSE METER. THE CONSUMER SUBSEQUENTLY EXPERIENCED A HYPOGLYCEMIC EVENT REQUIRING EMERGENT FOOD INTAKE TO RAISE HIS BLOOD SUGAR LEVEL. DURING THE CALL TO CUSTOMER SUPPORT, IT WAS REVEALED THAT THE CONSUMER HAS NEVER PERFORMED A CONTROL SOLUTION TEST ON TEST STRIPS TO CHECK THEIR INTEGRITY BEFORE USE AS INSTRUCTED IN OUR DIRECTIONS FOR USE. THE METER AND TEST STRIPS WILL BE RETURNED FOR EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BD PARADIGM LINK GLUCOSE MONITOR GLUCOSE MONITOR NBW NOVA BIOMEDICAL CORP. NA 1020210088

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention