BEUDAMED
    FDA Adverse Event Other Summary report: N

    NOVAMAX LINK GLUCOSE MONITOR

    MDR report key: 1200376 · Received October 10, 2008

    Report

    Report Number
    3004193489-2008-00588
    Event Type
    Other
    Date Received
    October 10, 2008
    Date of Event
    October 6, 2008
    Report Date
    October 10, 2008
    Manufacturer
    NOVA BIOMEDICAL CORPORATION
    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 RECEIVED A HIGH READING ON HER BLOOD GLUCOSE METER AND ADMINISTERED 7 UNITS OF INSULIN. SHE SUBSEQUENTLY EXPERIENCED A HYPOGLYCEMIC EVENT REQUIRING MEDICAL INTERVENTION. DURING THE ORIGINAL CALL, IT WAS REVEALED THAT THE CONSUMER STORES HER TEST STRIPS IN THE BATHROOM AND DOES NOT CONTROL SOLUTION TEST EACH NEW VIAL OF TEST STIRPS. BOTH OF THESE PRACTICES ARE AGAINST OUR DIRECTIONS FOR USE AND CAN COMPROMISE THE INTEGRITY OF THE TEST STIRPS. THE CONSUMER WILL RETURN THE METER AND DEVICE FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NOVAMAX LINK GLUCOSE MONITOR GLUCOSE MONITOR NBW NOVA BIOMEDICAL CORPORATION NA 1020208123

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention