BEUDAMED
    FDA Adverse Event Other Summary report: N

    NOVA MAX PLUS GLUCOSE MONITOR

    MDR report key: 3070211 · Received April 17, 2013

    Report

    Report Number
    3004193489-2013-00036
    Event Type
    Other
    Date Received
    April 17, 2013
    Date of Event
    April 6, 2013
    Report Date
    April 17, 2013
    Manufacturer
    NOVA BIOMEDICAL CORPORATION
    Product Code
    CGA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO NOVA BIOMEDICAL THAT A CONSUMER RECEIVED A "HI" (GREATER THAN 600 MG/DL) ON THEIR BLOOD GLUCOSE METER. THE CONSUMER REPORTED THAT THEY CALLED FOR EMERGENCY MEDICAL INTERVENTION BASED ON THE "HI" READING. WHEN THE EMTS ARRIVED THEY TESTED THE CONSUMER ON THEIR UNKNOWN BRAND OF A BLOOD GLUCOSE METER GETTING A RESULT OF 598 MG/DL. THE EMTS ADMINISTERED 7.5 CC TO THE CONSUMER. A CONTROL SOLUTION TEST WAS PERFORMED WHILE TROUBLESHOOTING WITH CUSTOMER SUPPORT SHOWING THE TEST STRIPS TO FALL IN RANGE AND THE METER AND TEST STRIPS WERE PERFORMING AS INTENDED. THE CONSUMER WAS ADVISED TO CONTACT THEIR HCP AS A FOLLOW-UP. THE METER AND TEST STRIPS ARE NOT BEING 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
    165654 NOVA MAX PLUS GLUCOSE MONITOR GLUCOSE MONITOR CGA NOVA BIOMEDICAL CORPORATION NA 1020212291

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention