BEUDAMED
    FDA Adverse Event Other Summary report: N

    BD PARADIGM LINK GLUCOSE MONITOR

    MDR report key: 1060893 · Received June 13, 2008

    Report

    Report Number
    3004193489-2008-00462
    Event Type
    Other
    Date Received
    June 13, 2008
    Date of Event
    June 5, 2008
    Report Date
    June 13, 2008
    Manufacturer
    NOVA BIOMEDICAL CORP.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, 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 RESULT OF 220 MG/DL ON THEIR BLOOD GLUCOSE METER. THE CONSUMER ADMINISTERED AN UNKNOWN AMOUNT OF INSULIN BASED ON THAT READING AND SUBSEQUENTLY EXPERIENCED A HYPOGLYCEMIC EVENT REQUIRING MEDICAL INTERVENTION AT A HOSPITAL. IT WAS DISCOVERED DURING THE PHONE CALL, THE CONSUMER IS STORING THE METER AND TEST STRIPS IN AN AREA WHICH MAY COMPROMISE THE INTEGRITY OF THE TEST STRIPS WHICH IS AGAINST OUR DIRECTIONS FOR USE. THE DIFFERENCE IN THE READINGS WAS DETERMINED TO BE CLINICALLY SIGNIFICANT. 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 CORP. NA 1020208017

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK