BEUDAMED
    FDA Adverse Event Other Summary report: N

    BD PARADIGM LINK GLUCOSE MONITOR

    MDR report key: 3919549 · Received June 17, 2014

    Report

    Report Number
    3004193489-2014-00047
    Event Type
    Other
    Date Received
    June 17, 2014
    Date of Event
    May 31, 2014
    Report Date
    May 31, 2014
    Manufacturer
    NOVA BIOMEDICAL CORPORATION
    Product Code
    NBW
    PMA / PMN Number
    K040603
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    TEST STRIP LOT # 1020413309, EXPIRATION DATE: 11/2015. CONTROL SOLUTION LOT: 1030713254, RANGE: 82-127 MG/DL. NOVA MAX TEST STRIP INSERT - QUALITY CONTROL CHECKING THE SYSTEM CONTROL SOLUTION TEST: THE NOVA MAX CONTROL SOLUTION IS USED AS A QUALITY CONTROL CHECK TO MAKE SURE THAT YOUR BLOOD GLUCOSE MONITOR AND THE NOVA MAX GLUCOSE TEST STRIPS ARE WORKING CORRECTLY. DO A CONTROL SOLUTION TEST: EACH TIME YOU OPEN A NEW VIAL OF TEST STRIPS. NOVA BIOMEDICAL AWAITS THE RETURN OF THE DEVICE FOR EVAL. SHOULD ANY SIGNIFICANT FINDINGS BE A RESULT OF THAT INVESTIGATION, A F/U REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO NOVA BIOMEDICAL THAT A CONSUMER WAS RECEIVING WHAT SHE FELT WERE INCONSISTENT BLOOD GLUCOSE READINGS. FEELING ILL, SHE HAD A NEIGHBOR TAKE HER TO THE HOSP. AN ADD'L CONVERSION WITH A HOSP STAFF EMPLOYEE IDENTIFIED A DIFFERENCE IN THE CONSUMER'S METER AND THE HOSP METER ALTHOUGH NO DIFFERENCE IN TIME IN BETWEEN READINGS WAS IDENTIFIED. TROUBLESHOOTING SHOWED THE CONSUMER'S DEVICE AND TEST STRIPS WERE PERFORMING AS INTENDED. THIS IS BEING REPORTED AS AN ADVERSE EVENT UNDER THE FDA MEDWATCH REGULATIONS. METER AND TEST STRIPS WILL BE RETURNED FOR EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    354955 BD PARADIGM LINK GLUCOSE MONITOR GLUCOSE MONITOR NBW NOVA BIOMEDICAL CORPORATION NA 1020413309

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention