BEUDAMED
    FDA Adverse Event Other Summary report: N

    BD PARADIGM LINK GLUCOSE MONITOR

    MDR report key: 1051777 · Received May 22, 2008

    Report

    Report Number
    3004193489-2008-00422
    Event Type
    Other
    Date Received
    May 22, 2008
    Date of Event
    April 22, 2008
    Report Date
    May 22, 2008
    Manufacturer
    NOVA BIOMEDICAL CORP
    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 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 258 MG/DL ON THEIR BLOOD GLUCOSE METER AT 6:45AM. THE CONSUMER ADMINISTERED 2.7 UNITS OF INSULIN. AT 7:30AM, THE CONSUMER EXPERIENCED A HYPOGLYCEMIC EVENT WHILE DRIVING AND HAD TO PULL OFF THE ROAD. THE CONSUMER IMMEDIATELY PERFORMED ANOTHER TEST USING THE SAME METER AND STRIPS GETTING A RESULT OF 211 MG/DL WHICH REQUIRED MEDICAL INTERVENTION. WHEN THE POLICE ARRIVED THEY CALLED FOR AN AMBULANCE TO TRANSFER THIS CONSUMER TO THE HOSP. APPROX AT 9:00AM, THE EMTS TESTED THIS CONSUMER USING THEIR BLOOD GLUCOSE METER GETTING A RESULT OF 27 MG/DL. THE EMTS ADMINISTERED GLUCOSE TO HELP RAISE THE CONSUMER'S BLOOD SUGAR LEVEL. IT WAS DISCOVERED DURING THE PHONE CALL, THIS CONSUMER IS STORING HER TEST STRIPS IN AN AREA WHICH IS AGAINST OUR DIRECTIONS FOR USE WHICH MAY COMPROMISE THE INTEGRITY OF THE TEST STRIPS. THE METER AND TEST STRIPS IN QUESTION WILL BE RETURNED FOR EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BD PARADIGM LINK GLUCOSE MONITOR GLUCOSE MONITOR NBW NOVA BIOMEDICAL CORP NA 1020407205

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK