BEUDAMED
    FDA Adverse Event Other Summary report: N

    NOVA MAX PLUS GLUCOSE MONITOR

    MDR report key: 2982524 · Received February 25, 2013

    Report

    Report Number
    3004193489-2013-00013
    Event Type
    Other
    Date Received
    February 25, 2013
    Date of Event
    February 1, 2013
    Report Date
    February 22, 2013
    Manufacturer
    NOVA BIOMEDICAL CORPORATION
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO NOVA BIOMEDICAL THAT A CONSUMER RECEIVED A RESULT OF "LO" (LESS THAN 20 MG/DL) ON THEIR UNKNOWN BLOOD GLUCOSE METER. DURING THE CALL TO CUSTOMER SUPPORT, THE CUSTOMER SERVICE REPRESENTATIVE NOTICED THE CONSUMER'S SPEECH WAS SLURRING AND WHEN ASKED IF SHE HAD ANYONE THERE WITH HER THE CONSUMER SAID, "YES, MY (B)(6)." THE CUSTOMER SERVICE REP FELT THE CONSUMER WAS EXPERIENCING A HYPOGLYCEMIC EVENT WHILE ON THE LINE AND OFFERED TO DIAL 911 FOR MEDICAL INTERVENTION ON BEHALF OF THIS CONSUMER. THE CONSUMER SAID, "YES" AND THE REPRESENTATIVE STAYED ON THE PHONE UNTIL THE EMTS ARRIVED. SEVERAL DAYS LATER, WHEN THE CUSTOMER SERVICE REPRESENTATIVE CALLED BACK THE CONSUMER TO GATHER ADDITIONAL INFORMATION, THE CONSUMER DECLINED TO PROVIDE ANY FURTHER INFORMATION REGARDING THE EVENT. THE METER AND TEST STRIPS WILL NOT BE RETURNED FOR EVALUATION. THIS IS BEING REPORTED AS AN ADVERSE EVENT UNDER THE FDA MEDWATCH REGULATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    79343 NOVA MAX PLUS GLUCOSE MONITOR GLUCOSE MONITOR NBW NOVA BIOMEDICAL CORPORATION NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention