BEUDAMED
    FDA Adverse Event Other Summary report: N

    BD PARADIGM LINK GLUCOSE MONITOR

    MDR report key: 2445501 · Received February 6, 2012

    Report

    Report Number
    3004193489-2012-00004
    Event Type
    Other
    Date Received
    February 6, 2012
    Date of Event
    January 25, 2012
    Report Date
    February 3, 2012
    Manufacturer
    NOVA BIOMEDICAL CORP
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, 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 CONTINUED TO GET HIGHER THAN EXPECTED RESULTS THROUGHOUT THE DAY. IT IS UNK IF THE CONSUMER ADMINISTRATED ANY INSULIN BASED ON THE HIGH RESULTS. THE CONSUMER'S SPOUSE REPORTED THAT THE CONSUMER EXPERIENCED A HYPOGLYCEMIC EVENT REQUIRING MEDICAL INTERVENTION. WHEN THE EMTS ARRIVED THEY TESTED THE CONSUMER GETTING A RESULT OF 33 MG/DL ON THEIR UNK BLOOD GLUCOSE METER. THE EMTS TESTED THE CONSUMER ON THE NOVA PARADIGM LINK METER GETTING A RESULT OF 311 MG/DL. DURING THE CALL TO CUSTOMER SUPPORT, IT WAS REVEALED THAT THE CONSUMER DOES NOT CONTROL SOLUTION TEST FOR INTEGRITY BEFORE USE THEIR INITIAL TEST STRIPS AS INSTRUCTED IN OUR DIRECTIONS FOR USE. IT WAS ALSO REVEALED THAT THE CONSUMER TRANSFERS TEST STRIPS FROM ONE VIAL TO ANOTHER, WHICH MAY CONTRIBUTE TO THE LOSS OF INTEGRITY OF THE TEST STRIPS. THE CONSUMER WAS EDUCATED ON THESE DIRECTIONS FOR USE AT THE TIME OF CALL. THE METER AND TEST STRIPS 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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention