BEUDAMED
    FDA Adverse Event Other Summary report: N

    NOVAMAX LINK GLUCOSE MONITOR

    MDR report key: 3133682 · Received May 24, 2013

    Report

    Report Number
    3004193489-2013-00048
    Event Type
    Other
    Date Received
    May 24, 2013
    Date of Event
    May 6, 2013
    Report Date
    May 23, 2013
    Manufacturer
    NOVA BIOMEDICAL CORP
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, 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 RESULT OF 424 MG/DL ON THEIR BLOOD GLUCOSE METER. THE CONSUMER ADMINISTERED 10 UNITS OF INSULIN BASED ON THAT RESULT. SUBSEQUENTLY SHE EXPERIENCED A HYPOGLYCEMIC EVENT THAT CAUSED THE CONSUMER TO FALL DOWN STAIRS REQUIRING MEDICAL INTERVENTION. THE CONSUMER'S PARENT DID NOT REPORT ANY INJURIES FROM THIS FALL. A CONTROL SOLUTION TEST WAS PERFORMED WHILE TROUBLESHOOTING WITH CUSTOMER SUPPORT SHOWING THE TEST STRIPS TO FALL IN RANGE. THE DIFFERENCE IN THE CONSUMER'S READINGS WAS DETERMINED TO BE CLINICALLY SIGNIFICANT. THE METER AND TEST STRIPS WILL BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    232653 NOVAMAX LINK GLUCOSE MONITOR GLUCOSE MONITOR NBW NOVA BIOMEDICAL CORP NA 1020412255

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention