BEUDAMED
    FDA Adverse Event Other Summary report: N

    NOVA MAX PLUS GLUCOSE MONITOR

    MDR report key: 4433151 · Received January 13, 2015

    Report

    Report Number
    3004193489-2015-00003
    Event Type
    Other
    Date Received
    January 13, 2015
    Report Date
    January 5, 2015
    Manufacturer
    NOVA BIOMEDICAL CORP
    Product Code
    NBW
    PMA / PMN Number
    K091547
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    TEST STRIP LOT # UNK. CONTROL SOLUTION LOT # 1030214093, RANGE: 82-127 MG/DL. NOVA MAX TEST STRIP INSERT - QUALITY CONTROL CHECKING THE SYSTEM CONTROL SOLUTION TEST: THE NOVA MAX CONTROL SOLUTION IS USED AS A QUALITY CONTROL CHECK TO MAKE SURE THAT YOUR BLOOD GLUCOSE MONITOR AND THE NOVA MAX GLUCOSE TEST STRIPS ARE WORKING CORRECTLY. DO A CONTROL SOLUTION TEST: EACH TIME YOU OPEN A NEW VIAL OF TEST STRIPS. 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 ON (B)(6) 2015, THAT SOMETIME IN (B)(6) 2014 THAT THE CONSUMER EXPERIENCED A HYPOGLYCEMIC EVENT WHICH DID NOT REQUIRE MEDICAL INTERVENTION. THE CONSUMER WAS NOT ABLE TO PROVIDE ANY OF THE INACCURATE READING RESULTS NOR COULD HE PROVIDE ANY FURTHER INFORMATION REGARDING THE REPORTED EVENT. THIS IS BEING REPORTED AS AN ADVERSE EVENT UNDER THE FDA MEDWATCH REGULATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    30028 NOVA MAX PLUS GLUCOSE MONITOR GLUCOSE MONITOR NBW NOVA BIOMEDICAL CORP NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK