BEUDAMED
    FDA Adverse Event Other Summary report: N

    NOVAMAX LINK GLUCOSE MONITOR

    MDR report key: 2934620 · Received January 25, 2013

    Report

    Report Number
    3004193489-2013-00001
    Event Type
    Other
    Date Received
    January 25, 2013
    Report Date
    January 24, 2013
    Manufacturer
    NOVA BIOMEDICAL CORPORATION
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    NOVA BIOMEDICAL AWAITS THE RETURN OF THE DEVICE FOR EVAL. SHOULD ANY SIGNIFICANT FINDINGS BE A RESULT OF THAT INVESTIGATION, A F/U REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO NOVA BIOMEDICAL ON (B)(4) 2013 THAT SOMETIME LAST WEEK, THE CONSUMER RECEIVED HIGHER THAN EXPECTED RESULTS ON HIS GLUCOSE METER. WHEN THE CONSUMER RECEIVED A RESULT OF "HI" (GREATER THAN 600 MG/DL) ON HIS GLUCOSE METER HE ADMINISTERED AN UNK AMOUNT OF INSULIN AND SUBSEQUENTLY EXPERIENCED A HYPOGLYCEMIC EVENT REQUIRING MEDICAL INTERVENTION. 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. IT WAS ALSO REVEALED THAT THE CONSUMER TRANSFERS TEST STRIPS FROM ONE VIAL TO ANOTHER, WHICH MAY CONTRIBUTE TO THE LOSS OF INTEGRITY OF THE TEST STRIPS. THE CONSUMER DID NOT HAVE ANY CONTROL SOLUTION TO PERFORM A TEST WHILE ON THE LINE. THE CONSUMER WAS EDUCATED ON THESE DIRECTIONS FOR USE AT THE TIME OF CALL. THE METER AND TEST STRIPS WILL BE RETURNED FOR EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    36074 NOVAMAX LINK GLUCOSE MONITOR GLUCOSE MONITOR NBW NOVA BIOMEDICAL CORPORATION NA 1020212101

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention