BEUDAMED
    FDA Adverse Event Other Summary report: N

    NOVAMAX LINK GLUCOSE MONITOR

    MDR report key: 2474186 · Received February 27, 2012

    Report

    Report Number
    3004193489-2012-00012
    Event Type
    Other
    Date Received
    February 27, 2012
    Date of Event
    February 20, 2012
    Report Date
    February 24, 2012
    Manufacturer
    NOVA BIOMEDICAL CORPORATION
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, 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 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 460 MG/DL ON THEIR BLOOD GLUCOSE METER. THE CONSUMER IMMEDIATELY PERFORMED ANOTHER TEST USING ANOTHER NOVA METER WITH THE SAME TEST STRIPS GETTING A RESULT OF 425 MG/DL. THE CONSUMER ADMINISTERED 5 - 6 UNITS OF INSULIN BASED ON THOSE RESULTS AND SUBSEQUENTLY EXPERIENCED A HYPOGLYCEMIC EVENT WHILE AT THE DR'S OFFICE FOR A SCHEDULED APPOINTMENT. THE CONSUMER REQUIRED EMERGENT FOOD INTERVENTION TO HELP RAISE HIS BLOOD GLUCOSE LEVEL. 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 OUT OF RANGE. THE CONSUMER WAS EDUCATED ON THESE DIRECTIONS FOR USE AT THE TIME OF CALL. THE TEST STRIPS AND METER WILL BE RETURNED FOR EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NOVAMAX LINK GLUCOSE MONITOR GLUCOSE MONITOR NBW NOVA BIOMEDICAL CORPORATION NA 1020211193

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention