BEUDAMED
    FDA Adverse Event Other Summary report: N

    NOVAMAX LINK GLUCOSE MONITOR

    MDR report key: 1943784 · Received December 17, 2010

    Report

    Report Number
    3004193489-2010-00277
    Event Type
    Other
    Date Received
    December 17, 2010
    Date of Event
    December 7, 2010
    Report Date
    December 17, 2010
    Manufacturer
    NOVA BIOMEDICAL CORP.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, 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 EXPERIENCED A HYPOGLYCEMIC EVENT REQUIRING MEDICAL INTERVENTION. DURING THE CALL TO CUSTOMER SUPPORT, IT WAS REVEALED THAT THE CONSUMER PERFORMED A BLOOD GLUCOSE TEST GETTING A RESULT OF 360 MG/DL BEFORE LUNCH. IT IS NOT CLEAR IF THE CONSUMER ADMINISTERED ANY INSULIN BASED ON THAT RESULT, IT IS ALSO UNKNOWN IF THE CONSUMER ATE BEFORE HE RETURNED TO BED FOR A NAP. SEVERAL HOURS LATER, THE CONSUMER'S DAUGHTER CALLED 911 BECAUSE SHE FOUND HER FATHER TO BE UNRESPONSIVE WHEN TRYING TO WAKE HIM UP. THE EMTS PERFORMED A BLOOD GLUCOSE TEST ON THE CONSUMER AND THE RESULT WAS 40 MG/DL. THE CONSUMER WAS TREATED WITH IV. THE CONSUMER'S DAUGHTER PERFORMED A TEST USING THE NOVA PRODUCT, GETTING A RESULT OF 162 MG/DL. THE DIFFERENCE IN THE CONSUMER'S READINGS WAS DETERMINED TO BE CLINICALLY SIGNIFICANT. THE METER AND TEST STRIPS IN REPORTED IN THIS EVENT WILL BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NOVAMAX LINK GLUCOSE MONITOR GLUCOSE MONITOR NBW NOVA BIOMEDICAL CORP. NA 1020209040

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention