BEUDAMED
    FDA Adverse Event Other Summary report: N

    NOVAMAX LINK GLUCOSE MONITOR

    MDR report key: 3777909 · Received April 22, 2014

    Report

    Report Number
    3004193489-2014-00023
    Event Type
    Other
    Date Received
    April 22, 2014
    Date of Event
    March 29, 2014
    Report Date
    March 29, 2014
    Manufacturer
    NOVA BIOMEDICAL CORP.
    Product Code
    NBW
    PMA / PMN Number
    K040603
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    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 THAT A CONSUMER STATED, "EMT SERVICE WAS CALLED TO HER HOME DUE TO HER BEING FOUND UNRESPONSIVE THIS MORNING BY HER HUSBAND." IT WAS REPORTED THAT A CONSUMER RECEIVED A RESULT OF 86 MG/DL ON HER BLOOD GLUCOSE METER. THE CONSUMER IMMEDIATELY PERFORMED TWO ADDITIONAL TESTS USING THE SAME METER AND STRIPS FROM THE SAME VIAL GETTING THE FOLLOWING RESULTS OF 260 MG/DL AND 66 MG/DL. THE CONSUMER EXPERIENCED A HYPOGLYCEMIC EVENT WHICH REQUIRED BOTH EMERGENT FOOD INTERVENTION TO HELP RAISE HER BLOOD SUGAR LEVEL AND WHEN THE EMTS ARRIVED, THEY OBSERVED AND DID NOT TREAT THIS CONSUMER. DURING THE CALL TO CUSTOMER SUPPORT, IT WAS REVEALED THAT THE CONSUMER DID NOT CONTROL SOLUTION TEST FOR INTEGRITY BEFORE USE 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 IN RANGE. THE DIFFERENCE IN THE CONSUMER'S READINGS WAS DETERMINED TO BE CLINICALLY SIGNIFICANT. THE METER AND TESTS STRIPS WILL BE RETURNED FOR EVALUATION. TEST STRIP LOT NUMBER 1020213155, EXPIRATION DATE: 06/2015. CONTROL SOLUTION LOT: 1030713254, RANGE: 82-127 MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    244522 NOVAMAX LINK GLUCOSE MONITOR GLUCOSE MONITOR NBW NOVA BIOMEDICAL CORP. NA 1020213155

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention