BEUDAMED
    FDA Adverse Event Other Summary report: N

    NOVAMAX LINK GLUCOSE MONITOR

    MDR report key: 2950429 · Received February 6, 2013

    Report

    Report Number
    3004193489-2013-00008
    Event Type
    Other
    Date Received
    February 6, 2013
    Date of Event
    January 17, 2013
    Report Date
    February 5, 2013
    Manufacturer
    NOVA BIOMEDICAL CORP.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, 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 BY THE SPOUSE OF THE CONSUMER THAT HE EXPERIENCED A HYPOGLYCEMIC EVENT REQUIRING MEDICAL INTERVENTION. THE CONSUMER RECEIVED A BLOOD GLUCOSE RESULT OF 160 MG/DL AND WAS FOUND ACTING ODD AND SEIZURE-LIKE. THE EMTS WERE CALLED AND IT IS UNK IF ANY MEDICATION OR NUTRITION TOOK PLACE AFTER THIS RESULT. WHEN THE EMTS ARRIVED THEY TESTED THE CONSUMER GETTING A RESULT OF 17 MG/DL. THE CONSUMER'S SPOUSE DID NOT PROVIDE ANY FURTHER INFO REGARDING THIS EVENT. THIS IS BEING REPORTED AS AN ADVERSE EVENT UNDER THE FDA MEDWATCH REGULATIONS. THE METER AND TEST STRIPS WILL BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    50677 NOVAMAX LINK GLUCOSE MONITOR GLUCOSE MONITOR NBW NOVA BIOMEDICAL CORP. NA 1020911227

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention