BEUDAMED
    FDA Adverse Event Other Summary report: N

    NOVAMAX LINK GLUCOSE MONITOR

    MDR report key: 3843695 · Received March 25, 2014

    Report

    Report Number
    3004193489-2014-00019
    Event Type
    Other
    Date Received
    March 25, 2014
    Date of Event
    February 22, 2014
    Report Date
    February 24, 2014
    Manufacturer
    NOVA BIOMEDICAL CORPORATION
    Product Code
    NBW
    PMA / PMN Number
    K040603
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    DURING THE CALL TO CUSTOMER SUPPORT, IT WAS REVEALED THAT THE CONSUMER DOES NOT CONTROL SOLUTION TEST FOR INTEGRITY BEFORE USING THEIR INITIAL TEST STRIPS AS INSTRUCTED IN OUR DIRECTIONS FOR USE. WHILE ON THE PHONE, A CONTROL SOLUTION COULD NOT BE PERFORMED BECAUSE THE CONSUMER DID NOT HAVE ANY NOVA MAX CONTROL SOLUTION. METER AND TEST STRIPS WILL BE RETURNED FOR EVALUATION. TEST STRIP LOT NUMBER 1020213212, EXPIRATION DATE: 07/2015. CONTROL SOLUTION LOT: NONE. 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, THAT "HE WAS RECEIVING INACCURATELY HIGH RESULTS WHEN TESTING HIS BLOOD GLUCOSE WHICH LED TO CALLING THE FIRE DEPARTMENT." THE CONSUMER RECEIVED A RESULT OF 205 MG/DL ON HIS METER AND TEST STRIPS. WHEN USING ANOTHER NOVA METER, AND POSSIBLY THE SAME TEST STRIPS RECEIVED A RESULT OF 70 MG/DL AND SUBSEQUENTLY EXPERIENCED A HYPOGLYCEMIC EVENT REQUIRING MEDICAL INTERVENTION. WHEN THE EMTS ARRIVED, THEY TESTED THE CONSUMER USING THEIR UNKNOWN EQUIPMENT, RESULT UNKNOWN. THE CONSUMER WAS NOT TREATED BY THE EMTS AND HE DECLINED TO GO TO THE HOSPITAL. THE CONSUMER REPORTED WHEN HE OPENED HIS TEST STRIP VIAL FROM THE BOX THE CAP DID NOT APPEAR TO BE FULLY CLOSED. CONSUMER ADMITTED, "I USED THESE STRIPS AGAINST MY BETTER JUDGMENT." THE OPEN CAP MAY HAVE CONTRIBUTED TO THE LOSS OF INTEGRITY OF THE TEST STRIPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    173845 NOVAMAX LINK GLUCOSE MONITOR GLUCOSE MONITOR NBW NOVA BIOMEDICAL CORPORATION NA 1020213212

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention