BEUDAMED
    FDA Adverse Event Other Summary report: N

    BD PARADIGM LINK GLUCOSE MONITOR

    MDR report key: 1063723 · Received June 20, 2008

    Report

    Report Number
    3004193489-2008-00479
    Event Type
    Other
    Date Received
    June 20, 2008
    Date of Event
    June 16, 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 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 ON THE EVENT DATE, THAT SOME TIME IN 2008, THE CONSUMER RECEIVED A HIGH READING OF 591 MG/DL ON HER BLOOD GLUCOSE METER. THE CONSUMER REPORTED THAT SHE ADMINISTERED 20 UNITS OF INSULIN. AT 1:55PM THE CONSUMER REPORTED SHE TESTED AGAIN GETTING A RESULT OF "HI" (HIGHER THAN 600 MG/DL) ON THEIR BLOOD GLUCOSE METER. THE CONSUMER ADMINISTERED 50 UNITS OF INSULIN BASED ON THAT RESULT. ACCORDING TO THE CONSUMER AT 3:00PM, SHE LAID DOWN AND PASSED OUT. AT 6:30PM HER HUSBAND CALLED FOR AN AMBULANCE. THE EMTS ARRIVED AT 7:00PM AND TESTED THE CONSUMER WITH THEIR BLOOD GLUCOSE METER GETTING A RESULT OF 36 MG/DL. CONSUMER WAS TREATED WITH IV GLUCOSE AND TRANSFERRED TO THE HOSPITAL. IT WAS DISCOVERED DURING THIS CALL, THE CONSUMER DOES NOT KEEP THE TEST STRIPS IN THEIR ORIGINAL VIAL. SHE STORES 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 CONSUMER ADMITTED SHE DOES NOT USE CONTROL WITH EVERY NEW VIAL OF TEST STRIPS AS INSTRUCTED IN OUR DIRECTIONS FOR USE. THE TEST STRIPS IN QUESTION WILL NOT BE RETURNED FOR EVALUATION BECAUSE THE TEST STRIPS HAVE BEEN DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BD PARADIGM LINK GLUCOSE MONITOR GLUCOSE MONITOR NBW NOVA BIOMEDICAL CORP. NA 1020208017

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK