BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PARADIGM LINK GLUCOSE MONITOR

    MDR report key: 1040927 · Received May 9, 2008

    Report

    Report Number
    3004193489-2008-00403
    Event Type
    Malfunction
    Date Received
    May 9, 2008
    Date of Event
    April 17, 2008
    Report Date
    May 9, 2008
    Manufacturer
    NOVA BIOMEDICAL CORP.
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    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 THAT A CONSUMER WAS EXPERIENCING AN ADVERSE EVENT AT THE TIME OF THE PHONE CALL. INFORMATION RECEIVED BEFORE MEDICAL INTERVENTION ARRIVED WAS THAT THE CONSUMER RECEIVED READINGS OF 567 MG/DL, 72 MG/DL AND 317 MG/DL WHILE ON THE TELEPHONE. OUR SUGGESTION OF ADMINISTERING ORANGE JUICE WAS TAKEN TO PREVENT THE CONSUMER FROM A MORE SEVERE HYPOGLYCEMIC EVENT. THE DIFFERENCE IN THE READINGS WAS DETERMINED TO BE CLINICALLY SIGNIFICANT. IT IS UNKNOWN IF THE METER AND TEST STRIPS INVOLVED IN THE EVENT WILL BE RETURNED. A FOLLOW-UP PHONE CALL WAS MADE TO THE CONSUMER, HOWEVER, THEY HAVE NOT RETURNED THE CALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BD PARADIGM LINK GLUCOSE MONITOR GLUCOSE MONITOR NBW NOVA BIOMEDICAL CORP. NA 7064116

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK