BEUDAMED
    FDA Adverse Event Other Summary report: N

    NOVAMAX LINK GLUCOSE MONITOR

    MDR report key: 2577530 · Received May 11, 2012

    Report

    Report Number
    3004193489-2012-00029
    Event Type
    Other
    Date Received
    May 11, 2012
    Date of Event
    May 1, 2012
    Report Date
    May 9, 2012
    Manufacturer
    NOVA BIOMEDICAL CORPORATION
    Product Code
    NBW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    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 COULD NOT BE PERFORMED WHILE ON THE LINE, THE CONSUMER HAD EXPIRED CONTROL SOLUTION, ((B)(6) 2009). THE CONSUMER WAS EDUCATED ON THESE DIRECTIONS FOR USE AT THE TIME OF CALL. THE METER AND TEST STRIPS WILL BE RETURNED FOR EVALUATION. 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 THE CONSUMER RECEIVED TWO "HI" READINGS, (GREATER THAN 600 MG/DL) ON HIS BLOOD GLUCOSE METER. THE CONSUMER REPORTED THAT HE COULD NOT REMEMBER IF HE ADMINISTERED ANY INSULIN OR ORAL MEDICATION BASED ON THESE RESULTS. THE CONSUMER WAS ALSO UNABLE TO REPORT THE TIMES OF HIS "HI" RESULTS. SUBSEQUENTLY, THE CONSUMER EXPERIENCED A HYPOGLYCEMIC EVENT, WAKING UP ON THE FLOOR. HE THEN CALLED FOR MEDICAL INTERVENTION AND WHEN THE EMTS ARRIVED THEY TESTED THE CONSUMER USING THEIR UNKNOWN BRAND OF GLUCOSE METER, GETTING A RESULT OF 49 MG/DL. THE CONSUMER WAS TRANSPORTED TO THE EMERGENCY ROOM FOR TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NOVAMAX LINK GLUCOSE MONITOR GLUCOSE MONITOR NBW NOVA BIOMEDICAL CORPORATION NA 1020210138

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention