BEUDAMED
    FDA Adverse Event Other Summary report: N

    BD PARADIGM LINK GLUCOSE MONITOR

    MDR report key: 1063721 · Received June 20, 2008

    Report

    Report Number
    3004193489-2008-00475
    Event Type
    Other
    Date Received
    June 20, 2008
    Date of Event
    June 13, 2008
    Report Date
    June 20, 2008
    Manufacturer
    NOVA BIOMEDICAL CORP.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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'S MOTHER REPORTED THAT HER SON, RECEIVED A RESULT OF 8.8 MMOL/DL (159 MG/DL) ON THEIR BLOOD GLUCOSE METER. HER SON EXPERIENCED A HYPOGLYCEMIC EVENT AFTER THAT READING. THE CONSUMER'S MOTHER CORRECTED THE EVENT BY HAVING THE CONSUMER EAT A SNACK AND ADMINISTERED AN UNK AMOUNT OF INSULIN. THE METER AND TEST STRIPS IN QUESTION WILL BE RETURNED 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 7064365

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention