BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NOVA MAX PLUS GLUCOSE MONITOR

    MDR report key: 4886504 · Received July 1, 2015

    Report

    Report Number
    3004193489-2015-00088
    Event Type
    Malfunction
    Date Received
    July 1, 2015
    Date of Event
    June 12, 2015
    Report Date
    June 20, 2015
    Manufacturer
    NOVA BIOMEDICAL CORP.,
    Product Code
    NBW
    PMA / PMN Number
    K091547
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE METER AND TEST STRIPS WILL BE RETURNED FOR EVALUATION. TEST STRIP LOT # 1020415009 EXPIRATION DATE: 01/2017. CONTROL SOLUTION LOT # 1030214093 RANGE: 82-127 MG/DL EXPIRED - OPEN GREATER THAN 90 DAYS. PER LABEL COPY/PACKAGE INSERT-UNEXPECTED RESULTS. HIGH OR LOW BLOOD GLUCOSE RESULTS CAN INDICATE POTENTIALLY SERIOUS MEDICAL CONDITIONS. IN CASE OF AN UNEXPECTED RESULT, YOU SHOULD REPEAT THE TEST USING A NEW TEST STRIP. IF THE RESULT IS STILL UNEXPECTED, OR THE READING IS NOT CONSISTENT WITH HOW YOU FEEL, CONTACT YOUR HCP AND TREAT AS PRESCRIBED. ANY CHANGE IN THE TREATMENT OF YOUR DIABETES SHOULD BE -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

    THE CONSUMER CALLED INTO CUSTOMER CARE CONCERNED, "ABOUT THE DIFFERENCE IN TWO (2) BLOOD GLUCOSE RESULTS THIS MORNING." IT WAS REPORTED TO NOVA BIOMEDICAL THAT A CONSUMER RECEIVED A RESULT OF 234 MG/DL ON HIS BLOOD GLUCOSE METER. THE CONSUMER IMMEDIATELY TESTED AGAIN USING THE SAME METER AND TEST STRIPS FROM THE SAME VIAL GETTING A RESULT OF 145 MG/DL. THE CONSUMER REPORTED THAT HE ADMINISTERED 35 UNITS OF INSULIN BASED THESE RESULTS. DURING THE CALL TO CUSTOMER SUPPORT, IT WAS REVEALED THAT THE CONSUMER USED EXPIRED CONTROL SOLUTION ON HIS TEST STRIPS TO DETERMINE THEIR INTEGRITY AND ACCURACY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    428746 NOVA MAX PLUS GLUCOSE MONITOR GLUCOSE MONITOR NBW NOVA BIOMEDICAL CORP., NA 1020415009

    Patients

    Seq Age Sex Outcome Treatment
    1