BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NOVA MAX PLUS GLUCOSE MONITOR

    MDR report key: 4671780 · Received April 8, 2015

    Report

    Report Number
    3004193489-2015-00035
    Event Type
    Malfunction
    Date Received
    April 8, 2015
    Date of Event
    March 11, 2015
    Report Date
    March 13, 2015
    Manufacturer
    NOVA BIOMEDICAL CORP
    Product Code
    CGA
    PMA / PMN Number
    K091547
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    TEST STRIP LOT #1020214027; EXPIRATION DATE: 1/2016; CONTROL SOLUTION LOT #1030514339; 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

    ON (B)(6) 2015, NOVA BIOMEDICAL RECEIVED THE FOLLOWING EMAIL FROM THE CONSUMER. "..I HAVE A NOVA MAX PLUS THAT IS GIVING ME SOME ISSUES, ONE READING WILL BE 22 BUT THIRTY SECONDS LATER IT WILL BE 97 ON THE SAME SAMPLE SITE. IT ALSO DOES THIS WITH KETONES WE'LL GE A .8 READING THEN WHEN WE RETEST IT WILL SAY LO JUST A FEW SECONDS LATER. IT HAS BEEN DOING THIS FOR A FEW WEEKS DO I NEED A NEW METER OR IS IT THE TEST STRIPS I CHECK AGAINST THE RECALL AND NONE OF MY NUMBERS WERE ON THERE. PLEASE HELP MY (B)(6) YR OLD HAS GSD 9 AND MONITORING IS VERY IMPORTANT TO BE ABLE TO DOES HIS MEDS. ANY HELP WOULD BE GREATLY APPRECIATED..." ON (B)(6) 2015, A FOLLOW UP PHONE CALL WAS MADE TO THE CONSUMER'S PARENT, HOWEVER, SHE WAS IN THE CAR AND WAS UNABLE TO PROVIDE ANY INFORMATION. ON (B)(6) 2015, ANOTHER FOLLOW-UP CALL WAS MADE TO THE CONSUMER'S PARENT, AND SHE WAS ABLE TO PROVIDE METER AND TEST STRIP LOT INFORMATION; SHE WAS ALSO ABLE TO PROVIDE RESULTS FROM THE METER'S HISTORY. ACCORDING TO THE CONSUMER'S PARENT, SHE PERFORMED A CONTROL SOLUTION TEST GETTING A RESULT OF 103 MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    231468 NOVA MAX PLUS GLUCOSE MONITOR GLUCOSE MONITOR CGA NOVA BIOMEDICAL CORP NA 1020214027

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK