BEUDAMED
    FDA Adverse Event Other Summary report: N

    BD PARADIGM LINK GLUCOSE MONITOR

    MDR report key: 1063722 · Received June 20, 2008

    Report

    Report Number
    3004193489-2008-00480
    Event Type
    Other
    Date Received
    June 20, 2008
    Date of Event
    June 16, 2008
    Report Date
    June 20, 2008
    Manufacturer
    NOVA BIOMEDICAL CORP.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, 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 AT 3:30PM. THE CONSUMER ADMINISTERED 25 UNITS OF INSULIN. AT 7:00PM,TESTED HERSELF, GETTING A RESULT OF 135 MG/DL AND AT 7:45PM, THE CONSUMER'S SPOUSE CALLED FOR AN AMBULANCE BECAUSE THE CONSUMER LOST CONSCIOUSNESS. WHEN THE EMTS TESTED THE CONSUMER WITH THEIR BLOOD GLUCOSE METER, RECEIVED A RESULT OF 29 MG/DL. WHEN THE HOSPITAL TESTED THE CONSUMER, THEY RECEIVED A RESULT OF 131 MG/DL. IT WAS DISCOVERED DURING THIS CALL, THE CONSUMER DOES NOT KEEP THE TEST STRIPS IN THEIR ORIGINAL VIAL. SHE STORES LOOSE TEST STRIPS IN HER CARRYING CASE WHICH IS AGAINST OUR DIRECTIONS FOR USE, AS IT MAY COMPROMISE THE INTEGRITY OF THE TEST STRIPS. CONSUMER ADMITTED SHE DOES NOT USE CONTROL WITH EVERY NEW VIAL OF TEST STRIPS AS INSTRUCTED IN OUR DIRECTIONS FOR USE. TEST STRIPS IN QUESTION WILL NOT BE RETURNED FOR EVALUATION BECAUSE THEY WERE DISCARDED.

    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