BEUDAMED
    FDA Adverse Event Other Summary report: N

    NOVA MAX PLUS GLUCOSE MONITOR

    MDR report key: 3777887 · Received April 22, 2014

    Report

    Report Number
    3004193489-2014-00024
    Event Type
    Other
    Date Received
    April 22, 2014
    Date of Event
    March 21, 2014
    Report Date
    March 29, 2014
    Manufacturer
    NOVA BIOMEDICAL CORP.
    Product Code
    NBW
    PMA / PMN Number
    K091547
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    TEST STRIP LOT NUMBER 1020413712, EXPIRATION DATE: 06/2015, CONTROL SOLUTION LOT NUMBER 1030713254 RANGE: 82-127 MG/DL. 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 CONSUMER STATING, "I WENT TO THE HOSPITAL DUE TO A BLOOD GLUCOSE READING OF 400 MG/DL I RECEIVED ON MY NOVA MAX METER." IT WAS ALSO REPORTED BY THE CONSUMER THAT AN HOUR LATER HE TESTED HIMSELF AGAIN GETTING A RESULT OF 361 MG/DL HE DECIDED TO GO TO THE CLINIC. TWO HOURS LATER HIS HCP, HEALTH CARE PROFESSIONAL TOLD HIM TO GO TO THE HOSPITAL. WHEN HE ARRIVED IN THE EMERGENCY ROOM, A NURSE PERFORMED A BLOOD GLUCOSE TEST ON THE CONSUMER, THE BLOOD GLUCOSE RESULT OF 227 MG/DL. ACCORDING TO THE CONSUMER HE WAS TREATED WITH IV FLUIDS WITH AN UNKNOWN MEDICATION AND RELEASED THREE HOURS LATER. THE CONSUMER ALLEGES A CONTROL SOLUTION TEST WAS PERFORMED AS INSTRUCTED IN THE DIRECTIONS FOR USE AND IT WAS IN RANGE, RESULT UNKNOWN. A CONTROL SOLUTION TEST WAS PERFORMED WHILE TROUBLESHOOTING WITH CUSTOMER SUPPORT SHOWING THE TEST STRIPS TO FALL IN RANGE. THE METER AND TEST STRIPS WILL BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    244339 NOVA MAX PLUS GLUCOSE MONITOR GLUCOSE MONITOR NBW NOVA BIOMEDICAL CORP. NA 1020413172

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention