BEUDAMED
    FDA Adverse Event Other Summary report: N

    BD PARADIGAM LINK GLUCOSE MONITOR

    MDR report key: 1003351 · Received February 27, 2008

    Report

    Report Number
    3004193489-2008-00224
    Event Type
    Other
    Date Received
    February 27, 2008
    Date of Event
    February 5, 2008
    Report Date
    February 27, 2008
    Manufacturer
    NOVA BIOMEDICAL CORP.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 THAT A CONSUMER REC'D A RESULT OF 305 MG/DL ON THEIR BLOOD GLUCOSE METER AT 4:00 PM. THE CONSUMER ADMINISTERED AN UNK AMOUNT OF INSULIN BASED ON THE READING. AT 8:00 PM THE CONSUMER TESTED AGAIN GETTING A RESULT OF 315 MG/DL AND AGAIN ADMINISTERED AN UNK AMOUNT OF INSULIN. THE CONSUMER EXPERIENCED A HYPOGLYCEMIC EVENT WHICH DID NOT REQUIRE ANY MEDICAL INTERVENTION. THE CONSUMER'S FRIEND GAVE HER PEANUT BUTTER, HONEY AND MILK TO HELP RAISE THE BLOOD SUGAR LEVEL. AT 11:15 PM, THE CONSUMER TESTED AGAIN GETTING A RESULT OF 42 MG/DL. IT WAS FOUND DURING THE PHONE CALL, THE CONSUMER USED TEST STRIPS FROM A VIAL WHICH SHE LEFT THE LID OFF, WHICH IS AGAINST OUR DIRECTIONS FOR USE AND MAY HAVE AFFECTED THE INTEGRITY OF THE TEST STRIPS. THE DIFFERENCE IN THE READINGS WAS DETERMINED TO BE CLINICALLY SIGNIFICANT. THE TEST STRIPS IN QUESTION WILL BE RETURNED FOR EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BD PARADIGAM LINK GLUCOSE MONITOR GLUCOSE MONITOR NBW NOVA BIOMEDICAL CORP. NA 7064160

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK