BEUDAMED
    FDA Adverse Event Other Summary report: N

    NOVA MAX PLUS GLOCOSE MONITOR

    MDR report key: 4274053 · Received November 20, 2014

    Report

    Report Number
    3004193489-2014-00106
    Event Type
    Other
    Date Received
    November 20, 2014
    Report Date
    October 21, 2014
    Manufacturer
    NOVA BIOMEDICAL CORP
    Product Code
    NBW
    PMA / PMN Number
    K091547
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    RELATED MDR: 3004193489-2014-00093. TEST STRIP LOT #1020213354, EXPIRATION DATE: 12/2015, CONTROL SOLUTION LOT# NONE. NOVA MAX 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 VIA EMAIL FROM THE SPOUSE OF THE CONSUMER THAT THE CONSUMER WAS BROUGHT TO THE EMERGENCY ROOM BECAUSE SHE WAS DIZZY OVER THE WEEKEND. ACCORDING TO THE INFORMATION PROVIDED IN THE EMAIL; THE CONSUMER'S SPOUSE REPORTED THAT, "I USED MY METER GETTING A RESULT OF 303, 'BP' WAS 196 AND I DID BLOOD 3 MORE TIMES IN THE 300 AREA, BROUGHT IN A 'REG NURSE' SHE USED MY METER, SHE LEFT TO FIND INSULIN AND CAME AND CHECKED MY METER WITH UNKNOWN BRAND OF CONTROL SOLUTION AND IT READ 295, SHE SAID, 'MY STRIPS WERE NOT GOOD.' SHE TRIED HER PERSONAL UNKNOWN BRAND OF METER GETTING A RESULT OF 103." THE EMAIL DID NOT PROVIDE THE FOLLOWING: INFORMATION REGARDING DATES OF REPORTED EVENTS; TIME LINE OF ANY BLOOD GLUCOSE RESULTS AND THE SERIAL LOT NUMBERS OF GLUCOSE METER, CONTROL SOLUTION OR DATES IF HOSPITALIZATION. THIS BEING REPORTED AS AN ADVERSE EVENT UNDER THE FDA MEDWATCH REGULATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    753380 NOVA MAX PLUS GLOCOSE MONITOR GLUCOSE MONITOR NBW NOVA BIOMEDICAL CORP NA 1020213354

    Patients

    Seq Age Sex Outcome Treatment
    1