BEUDAMED
    FDA Adverse Event Other Summary report: N

    BD PARADIGM LINK GLUCOSE MONITOR

    MDR report key: 1300732 · Received January 30, 2009

    Report

    Report Number
    3004193489-2009-00021
    Event Type
    Other
    Date Received
    January 30, 2009
    Date of Event
    January 26, 2009
    Report Date
    January 30, 2009
    Manufacturer
    NOVA BIOMEDICAL CORP.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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 MISTREATED HERSELF BASED ON HIGH READINGS OBTAINED ON HER BLOOD GLUCOSE METER AND EXPERIENCED A HYPOGLYCEMIC EVENT NOT REQUIRING MEDICAL INTERVENTION. IT WAS REVEALED DURING THE CALL THAT THE CONSUMER DOES NOT STORE HER TEST STRIPS APPROPRIATELY AND DOES NOT PRACTICE CONTROL SOLUTION TESTING AS RECOMMENDED IN NOVA'S DIRECTION FOR USE. THE METER 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 7064061

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention