BEUDAMED
    FDA Adverse Event Other Summary report: N

    BD PARADIGM LINK GLUCOSE MONITOR

    MDR report key: 1003352 · Received February 27, 2008

    Report

    Report Number
    3004193489-2008-00219
    Event Type
    Other
    Date Received
    February 27, 2008
    Date of Event
    February 4, 2008
    Report Date
    February 27, 2008
    Manufacturer
    NOVA BIOMEDICAL CORPORATION
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, 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 IN 2007, THE CONSUMER RECEIVED HIGH READINGS, AND ACCORDING TO THE CONSUMER, SHE TWO MONTHS LATER ADMINISTERED INSULIN BASED ON THE READINGS. THE CONSUMER SUBSEQUENTLY EXPERIENCED A HYPOGLYCEMIC EVENT WHICH DID REQUIRE MEDICAL INTERVENTION IN THE EMERGENCY ROOM. THE EMERGENCY ROOM TESTED THE CONSUMER GETTING A RESULT OF 39 MG/DL. IT WAS FOUND DURING THE CALL THAT THE CONSUMER REMOVED THE TEST STRIPS FROM THE VIAL AND PLACED THEM LOOSELY IN CARRYING CASE, WHICH IS AGAINST OUR DIRECTIONS FOR USE, WHICH MAY AFFECT THE INTEGRITY OF THE TEST STRIPS. THE METER AND 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 CORPORATION NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK