BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NOVA MAX LINK GLUCOSE MONITOR

    MDR report key: 5161973 · Received October 20, 2015

    Report

    Report Number
    3004193489-2015-00140
    Event Type
    Malfunction
    Date Received
    October 20, 2015
    Date of Event
    September 23, 2015
    Report Date
    September 24, 2015
    Manufacturer
    NOVA BIOMEDICAL CORP.,
    Product Code
    NBW
    PMA / PMN Number
    K040603
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    TEST STRIP LOT # 1020215050, EXPIRATION DATE: 2017/02/28, CONTROL SOLUTION LOT # 1030314175, CSR 82-127 MG/DL. THE CUSTOMER'S COMPLAINT IS CONFIRMED. FAILURE ANALYSIS OF THE RETURNED DEVICE REVEALED THAT THE NOVA MAX LINK GLUCOSE MONITORING DEVICE PERFORMED WITHIN SPECIFICATION. VISUAL AS WELL AS CHEMICAL EVALUATION (BY TESTING WITH CONTROL SOLUTION) OF THE RETURNED GLUCOSE TEST STRIPS REVEALED THE STRIPS TO BE COMPROMISED. THE ROOT CAUSE COULD NOT BE CONCLUSIVELY IDENTIFIED. A POTENTIAL CONTRIBUTORY ROOT CAUSE MAY BE RELATED TO EXPOSURE OF THE TEST STRIPS TO EXTREMES IN TEMPERATURE CONTRARY TO THE STORAGE AND HANDLING AS INDICATED IN LABEL COPY (IFU/PACKAGE INSERT) THIS IS FURTHER SUPPORTED BY THE RESULTS OF THE RETAIN STRIP TESTING WHICH INDICATES THE PERFORMANCE OF THE RETAIN STRIPS ARE WITHIN PRODUCT SPECIFICATION.

    Description of Event or Problem · 1

    CONSUMER CALLED IN CONCERNED ABOUT THE DISCREPANCY IN HER BG READINGS BETWEEN HER NOVA MAX LINK AND HER ONE TOUCH. (B)(6) 2015 AT 5:20 PM BG 107MG/DL NML THE CONSUMER STATED, "...SHE FELT LOWER....", AT 5:21 PM BG 48 MG/DL ONE TOUCH. (B)(6) 2015 AT 11:16 AM BG 118 MG/DL NML THE CONSUMER STATED, "...SHE FELT LOWER....", AT 11:17 AM BG 56 ONE TOUCH. THE CONSUMER ALLEGES A CONTROL SOLUTION TEST WAS PERFORMED AS INSTRUCTED IN THE DIRECTIONS FOR USE ON (B)(6) 2015. HOWEVER, IT IS UNKNOWN IF THE RESULTS WERE IN OR OUT OF CONTROL RANGE. A CONTROL SOLUTION TEST WAS PERFORMED WHILE TROUBLESHOOTING WITH CUSTOMER SUPPORT SHOWING THE TEST STRIPS TO FALL OUT OF RANGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    693218 NOVA MAX LINK GLUCOSE MONITOR GLUCOSE MONITOR NBW NOVA BIOMEDICAL CORP., N/A 1020215050

    Patients

    Seq Age Sex Outcome Treatment
    1