BEUDAMED
    FDA Adverse Event Other Summary report: N

    BD PARADIGM LINK GLUCOSE MONITOR

    MDR report key: 1202929 · Received October 17, 2008

    Report

    Report Number
    3004193489-2008-00597
    Event Type
    Other
    Date Received
    October 17, 2008
    Date of Event
    October 9, 2008
    Report Date
    October 17, 2008
    Manufacturer
    NOVA BIOMEDICAL CORPORATION
    Product Code
    NBW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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 HIGH BLOOD GLUCOSE RESULTS AND ADMINISTERED INSULIN BASED ON THOSE HIGH READINGS. HE SUBSEQUENTLY EXPERIENCED A HYPOGLYCEMIC EVENT. THE BLOOD GLUCOSE METER WAS READING HIGH (434 MG/DL) AND THE HOSPITAL READING WAS CONSIDERABLY LOWER (86 MG/DL). DURING THE CALL TO CUSTOMER SERVICE, IT WAS REVEALED THAT THE CONSUMER STORES HIS BLOOD TESTING SUPPLIES IN THE KITCHEN AND HAD NO CONTROL SOLUTION SUPPLIES, WHICH IS AGAINST THE DIRECTIONS FOR USE OF THE BLOOD TESTING DEVICE. THESE PRACTICES CAN COMPROMISE THE INTEGRITY OF THE TEST STRIPS. CONSUMER EDUCATION TOOK PLACE AT THE SAME TIME OF THE ORIGINAL CALL. NO PRODUCT 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 CORPORATION NA 1020208052

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization| R