BEUDAMED
    FDA Adverse Event Other Summary report: N

    BD PARADIGM LINK GLUCOSE MONITOR

    MDR report key: 1202935 · Received October 17, 2008

    Report

    Report Number
    3004193489-2008-00594
    Event Type
    Other
    Date Received
    October 17, 2008
    Date of Event
    September 29, 2008
    Report Date
    October 17, 2008
    Manufacturer
    NOVA BIOMEDICAL CORP.
    Product Code
    NBW
    Adverse Event
    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 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 RECEIVED 81 MG/DL, 74 MG/DL AND 77 MG/DL BLOOD GLUCOSE READINGS THROUGHOUT THE EVENING ON HER BLOOD GLUCOSE METER, BUT SUBSEQUENTLY EXPERIENCED A HYPOGLYCEMIC EVENT, REQUIRING MEDICAL INTERVENTION AND HOSPITALIZATION. DURING THE CALL TO CUSTOMER CARE SERVICE, IT WAS REVEALED THAT THE CONSUMER STORES THEIR BLOOD TESTING EQUIPMENT IN THE KITCHEN, WHICH IS CONTRARY TO OUR DIRECTIONS FOR USE OF STORAGE. THIS PRACTICE CAN COMPROMISE THE INTEGRITY OF THE TEST STRIPS. THE CONSUMER WILL RETURN THE BLOOD GLUCOSE METER AND TEST STRIPS THAT WERE USED DURING THE EVENT FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BD PARADIGM LINK GLUCOSE MONITOR GLUCOSE MONITOR NBW NOVA BIOMEDICAL CORP. NA 1020208053

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization