BEUDAMED
    FDA Adverse Event Other Summary report: N

    BD PARADIGM LINK GLUCOSE MONITOR

    MDR report key: 1182453 · Received September 12, 2008

    Report

    Report Number
    3004193489-2008-00552
    Event Type
    Other
    Date Received
    September 12, 2008
    Date of Event
    August 19, 2008
    Report Date
    September 12, 2008
    Manufacturer
    NOVA BIOMEDICAL CORP.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, 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 "HI" (GREATER THAN 600 MG/DL) ON THEIR BLOOD GLUCOSE METER. THE CONSUMER ADMINISTERED SIX (6) UNITS OF INSULIN BASED ON THE "HI" READING. THE CONSUMER RECOGNIZED IMMEDIATELY THAT HIS BLOOD GLUCOSE WAS DROPPING. THE CONSUMER ATE TO COUNTERACT THE INSULIN TREATMENT. DURING THE CALL TO CUSTOMER SUPPORT, IT WAS REVEALED THAT THE CONSUMER DOES NOT CONTROL SOLUTION TEST THEIR TEST STRIPS BEFORE USE AS INSTRUCTED IN OUR DIRECTIONS FOR USE. THE CONSUMER WAS EDUCATED ON THESE DIRECTIONS FOR USE AT THE TIME OF CALL. THE METER AND THE 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 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK