BEUDAMED
    FDA Adverse Event Other Summary report: N

    NOVA MAX PLUS GLUCOSE MONITOR

    MDR report key: 3772784 · Received March 3, 2014

    Report

    Report Number
    3004193489-2014-00018
    Event Type
    Other
    Date Received
    March 3, 2014
    Date of Event
    February 23, 2014
    Report Date
    February 24, 2014
    Manufacturer
    NOVA BIOMEDICAL CORP.
    Product Code
    NBW
    PMA / PMN Number
    K091547
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    TEST STRIP LOT # 1020413172, EXP DATE: 06/2015. CONTROL SOLUTION LOT: 1030713254, 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 BY THE CONSUMER'S DAUGHTER-IN-LAW, "THE CONSUMER WAS RECEIVING BLOOD GLUCOSE RESULTS THAT WERE TOO HIGH, CAUSING A HYPOGLYCEMIC EVENT AND THE EMTS HAVING TO BE CALLED". THE CONSUMER'S DAUGHTER-IN-LAW REPORTED THAT THE CONSUMER WAS FOUND BY THE CAREGIVER FLAILING HIS ARMS, LEGS AND WAS SCREAMING. WHEN THE EMTS ARRIVED THEY TESTED THE CONSUMER GETTING A RESULT OF 40 MG/DL ON THEIR UNK BRAND OF METER. DURING THE CALL TO CUSTOMER SUPPORT, IT WAS REVEALED THAT THE CONSUMER DID NOT CONTROL SOLUTION TEST FOR INTEGRITY BEFORE USING THEIR INITIAL TEST STRIPS AS INSTRUCTED IN OUR DIRECTIONS FOR USE. A CONTROL SOLUTION TEST WAS PERFORMED WHILE TROUBLESHOOTING WITH CUSTOMER SUPPORT SHOWING THE TEST STRIPS TO FALL OUT OF RANGE. THE TEST STRIPS WILL BE RETURNED FOR EVAL. HOWEVER, THE METER WILL NOT BE RETURNED BECAUSE IT WAS DISCARDED BY THE CONSUMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    128414 NOVA MAX PLUS GLUCOSE MONITOR GLUCOSE MONITOR NBW NOVA BIOMEDICAL CORP. NA 1020413172

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention