BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NOVA MAX LINK GLUCOSE MONITOR

    MDR report key: 4771499 · Received May 13, 2015

    Report

    Report Number
    3004193489-2015-00056
    Event Type
    Malfunction
    Date Received
    May 13, 2015
    Date of Event
    April 18, 2015
    Report Date
    April 18, 2015
    Manufacturer
    NOVA BIOMEDICAL CORPORATION
    Product Code
    NBW
    PMA / PMN Number
    K040603
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    RELATED MDR: 3004193489-2015-00057. TEST STRIP LOT # 1020214365, EXPIRATION DATE: 12/2016, CONTROL SOLUTION LOT # 1030113018, EXPIRATION: 06/2015. 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 HER READING SHE RECEIVED THIS MORNING USING HER "BACK-UP" METER FOR TESTING. ACCORDING TO THE CONSUMER SHE PERFORMED A BLOOD GLUCOSE TEST AT 8:37 AM ON (B)(6) 2015 GETTING A RESULT OF 304 MG/DL. THE CONSUMER REPORTED THAT SHE ADMINISTERED 4 UNITS OF INSULIN BASED ON THAT RESULT. DURING THE CALL TO CUSTOMER SUPPORT, IT WAS REVEALED THAT THE CONSUMER DID NOT PERFORM A CONTROL SOLUTION TEST FOR INTEGRITY BEFORE USING THEIR INITIAL TEST STRIPS AS INSTRUCTED IN OUR DIRECTIONS FOR USE. A CONTROL SOLUTION TEST WAS NOT PERFORMED WHILE ON THE PHONE WITH CUSTOMER CARE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    313137 NOVA MAX LINK GLUCOSE MONITOR GLUCOSE MONITOR NBW NOVA BIOMEDICAL CORPORATION NA 1020214365

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other