BEUDAMED
    FDA Adverse Event Other Summary report: N

    BD PARADIGM LINK GLUCOSE MONITOR

    MDR report key: 1060900 · Received June 13, 2008

    Report

    Report Number
    3004193489-2008-00466
    Event Type
    Other
    Date Received
    June 13, 2008
    Date of Event
    June 11, 2008
    Report Date
    June 13, 2008
    Manufacturer
    NOVA BIOMEDICAL CORPORATION DIABETES PRODUCTS
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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 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 396 MG/DL ON THEIR BLOOD GLUCOSE METER AT 6:07 AM. THE CONSUMER ADMINISTERED 6 EXTRA UNITS OF INSULIN. AT 9:04AM THE CONSUMER TESTED AGAIN GETTING A RESULT OF 322 MG/DL. THE CONSUMER EXPERIENCED A HYPOGLYCEMIC EVENT AND HAD A SEIZURE. AT 9:56AM HIS FIANCÉ TESTED HIM AND RECEIVED A RESULT OF 296 MG/DL AND THE CONSUMER EXPERIENCED ANOTHER SEIZURE, AT THIS TIME, THE FIANCÉ CALLED FOR MEDICAL INTERVENTION. AT 10:16 AM, THE PARAMEDICS TESTED THE CONSUMER WITH THE NOVA METER AND STRIPS GETTING A RESULT OF 338 MG/DL. THEN THEY TESTED WITH THEIR FREESTYLE GLUCOSE METER GETTING A RESULT OF 42 MG/DL. PARAMEDIS ADMINISTERED IV GLUCOSE. WHEN THE CONSUMER ARRIVED AT THE HOSPITAL, THEY TESTED HIM AGAIN, GETTING A RESULT OF 148 MG/DL AND WAS GIVEN APPLESAUCE AND SODA. IT WAS DISCOVERED THE CONSUMER WAS USING EXPIRED TEST STRIPS WHICH IS AGAINST OUR DIRECTIONS FOR USE. THE DIFFERENCE IN THE READINGS WAS DETERMINED TO BE CLINICALLY SIGNIFICANT. THE TEST STRIPS IN QUESTION WILL NOT BE RETURNED FOR EVAL, REP ADVISED THE CONSUMER TO DISCARD EXPIRED TEST STRIPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BD PARADIGM LINK GLUCOSE MONITOR GLUCOSE MONITOR NBW NOVA BIOMEDICAL CORPORATION DIABETES PRODUCTS NA 6064097

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK