BEUDAMED
    FDA Adverse Event Other Summary report: N

    BD PARADIGM LINK GLUCOSE MONITOR

    MDR report key: 1202888 · Received October 17, 2008

    Report

    Report Number
    3004193489-2008-00595
    Event Type
    Other
    Date Received
    October 17, 2008
    Date of Event
    October 10, 2008
    Report Date
    October 17, 2008
    Manufacturer
    NOVA BIOMEDICAL CORPORATION
    Product Code
    NBW
    Adverse Event
    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 HIGH BLOOD GLUCOSE READING, AND TREATED HERSELF WITH INSULIN FOR THE HIGH READING AND SUBSEQUENTLY, EXPERIENCED A HYPOGLYCEMIC EVENT, WHICH REQUIRED MEDICAL INTERVENTION. DURING THE CALL TO CUSTOMER SUPPORT, IT WAS REVEALED THAT THE CONSUMER DOES NOT CONTROL SOLUTION TEST HER TEST STRIPS BEFORE USE, AS INSTRUCTED IN OUR DIRECTIONS FOR USE. IT WAS ALSO REPORTED THAT THE CONSUMER IMPROPERLY STORES THEIR TEST STRIPS. THE CONSUMER WAS EDUCATED ON THESE DIRECTIONS FOR USE AT THE TIME OF THE CALL. THE METER AND TEST STRIPS 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 1020208073

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention