BEUDAMED
    FDA Adverse Event Other Summary report: N

    NOVA MAX PLUS GLUCOSE MONITOR

    MDR report key: 3433020 · Received October 21, 2013

    Report

    Report Number
    3004193489-2013-00105
    Event Type
    Other
    Date Received
    October 21, 2013
    Date of Event
    September 18, 2013
    Report Date
    September 21, 2013
    Manufacturer
    NOVA BIOMEDICAL CORPORATION
    Product Code
    NBW
    PMA / PMN Number
    K091547
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    EXPIRATION DATE OF REPORTED TEST STRIPS: 1020213154 06/2015. 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. ACCORDING TO THE CONSUMER HE LAST TESTED HIMSELF AT 11:00PM ON (B)(6) 2013. THE NEXT MORNING AT 10:30 AM ON (B)(6) 2013 PARAMEDICS WERE CALLED. WHEN THEY ARRIVED THEY TESTED THE CONSUMER GETTING A RESULT OF 30 MG/DL ON THEIR UNKNOWN BLOOD GLUCOSE METER. THE CONSUMER WAS TRANSPORTED TO THE HOSPITAL AND RELEASED. IT IS UNKNOWN IF THE CONSUMER PERFORMED ANY TESTING ON THE NOVA BIOMEDICAL BLOOD GLUCOSE METER PRIOR TO THE PARAMEDICS ARRIVAL. DURING THE CALL TO CUSTOMER SUPPORT, IT WAS REVEALED THAT THE CONSUMER DOES NOT CONTROL SOLUTION TEST FOR INTEGRITY BEFORE USE THEIR INITIAL TEST STRIPS AS INSTRUCTED IN OUR DIRECTIONS FOR USE. THE CONSUMER WAS EDUCATED ON THESE DIRECTIONS FOR USE AT THE TIME OF CALL. THE METER AND TEST STRIPS WILL 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
    537929 NOVA MAX PLUS GLUCOSE MONITOR GLUCOSE MONITOR NBW NOVA BIOMEDICAL CORPORATION NA 1020213154

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention