BEUDAMED
    FDA Adverse Event Other Summary report: N

    NOVA MAX PLUS GLUCOSE MONITOR

    MDR report key: 3530210 · Received December 6, 2013

    Report

    Report Number
    3004193489-2013-00140
    Event Type
    Other
    Date Received
    December 6, 2013
    Date of Event
    November 18, 2013
    Report Date
    November 26, 2013
    Manufacturer
    NOVA BIOMEDICAL CORP
    Product Code
    NBW
    PMA / PMN Number
    K091547
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    TEST STRIP LOT #1020413172, EXPIRATION DATE: 06/2015, CONTROL SOLUTION 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) 2013 BY THE CONSUMER THAT "...MY METER HAS BEEN READING HIGH GOING ON FOR THREE (3) MONTHS." SHE WAS ADMITTED TO THE HOSPITAL AS A RESULT OF HIGH READINGS FROM (B)(6) 2013 WITH HIGH BLOOD GLUCOSE LEVELS AND HIGH BLOOD PRESSURE. DURING THE CALL TO CUSTOMER SUPPORT, IT WAS REVEALED THAT THE CONSUMER DID NOT PERFORM A CONTROL SOLUTION TEST FOR INTEGRITY BEFORE USE THEIR INITIAL TEST STRIPS AS INSTRUCTED IN OUR DIRECTIONS FOR USE. IT WAS ALSO REVEALED THAT THE CONSUMER WAS USING EXPIRED TEST STRIP, WHICH MAY CONTRIBUTE TO THE LOSS OF INTEGRITY OF THE TEST STRIPS. THE METER AND TEST STRIPS WILL BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    634454 NOVA MAX PLUS GLUCOSE MONITOR GLUCOSE MONITOR NBW NOVA BIOMEDICAL CORP NA 102412172

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization| R