BEUDAMED
    FDA Adverse Event Other Summary report: N

    BD PARADIGM LINK GLUCOSE MONITOR

    MDR report key: 1063720 · Received June 20, 2008

    Report

    Report Number
    3004193489-2008-00469
    Event Type
    Other
    Date Received
    June 20, 2008
    Date of Event
    June 5, 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 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 ON THE EVENT DATE, THAT A CONSUMER IN 2007, HAD AN INCIDENT USING THE NOVA BLOOD GLUCOSE METER. CONSUMER STATED THAT AROUND 2:45 PM SHE TESTED HERSELF USING HER "PURSE METER" GETTING A RESULT IN THE 400'S. THE CONSUMER BOLUSED AN UNK AMOUNT OF INSULIN BASED THAT READING. SUBSEQUENTLY, WHILE DRIVING, THE CONSUMER EXPERIENCED A HYPOGLYCEMIC EVENT AND GOT INTO AN ACCIDENT. APPROX 4:00 PM. THE CONSUMER WAS TAKEN TO THE HOSP IN AN AMBULANCE. IN THE AMBULANCE THE EMTS TESTED THE CONSUMER GETTING A RESULT OF 43 MG/DL ON THEIR UNK METER. THE EMTS TREATED THE CONSUMER WITH IV GLUCOSE. IT WAS DISCOVERED DURING THIS CALL, THE CONSUMER DOES NOT KEEP THE TEST STRIPS IN THE ORIGINAL VIAL AS DIRECTED. ACCORDING TO THE CONSUMER, SHE "DUMPS" LOOSE TEST STRIPS IN HER CARRYING CASE WHICH IS AGAINST OUR DIRECTIONS FOR USE AS IT MAY COMPROMISE THE INTEGRITY OF THE TEST STRIPS. THE METER AND TEST STRIPS IN QUESTION WILL NOT BE RETURNED FOR EVAL, BECAUSE THE TEST STRIPS HAVE ALL BEEN USED UP BY THE CONSUMER.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK