BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NOVAMAX LINK GLUCOSE MONITOR

    MDR report key: 2121743 · Received May 20, 2011

    Report

    Report Number
    3004193489-2011-00049
    Event Type
    Malfunction
    Date Received
    May 20, 2011
    Date of Event
    May 10, 2011
    Report Date
    May 20, 2011
    Manufacturer
    NOVA BIOMEDICAL CORP
    Product Code
    NBW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 RECEIVED A RESULT OF 68 MG/DL ON THEIR BLOOD GLUCOSE METER. THE CONSUMER ATE AND BOLUSED 1 UNIT OF INSULIN FOR HER LUNCH. TWO HOURS LATER, THE CONSUMER 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. THE CONSUMER WAS EDUCATED ON THE DIRECTIONS FOR USE AT THE TIME OF CALL. WHILE ON THE CALL TO CUSTOMER SUPPORT, A CONTROL SOLUTION TEST WAS PERFORMED WHILE TROUBLESHOOTING SHOWING THE TEST STRIPS FELL OUT OF RANGE. THE METER AND TEST STRIPS WILL BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NOVAMAX LINK GLUCOSE MONITOR GLUCOSE MONITOR NBW NOVA BIOMEDICAL CORP NA 1020210088

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention