BEUDAMED
    FDA Adverse Event Other Summary report: N

    NOVAMAX LINK GLUCOSE MONITOR

    MDR report key: 1182451 · Received September 12, 2008

    Report

    Report Number
    3004193489-2008-00557
    Event Type
    Other
    Date Received
    September 12, 2008
    Date of Event
    August 25, 2008
    Report Date
    September 12, 2008
    Manufacturer
    NOVA BIOMEDICAL CORP.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, 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 194 MG/DL ON THEIR BLOOD GLUCOSE METER AT MIDNIGHT. THE CONSUMER ADMINISTERED 5 UNITS OF INSULIN VIA THE PUMP AND THEN WENT TO BED. APPROXIMATELY, 4:10AM THE CONSUMER'S SPOUSE NOTICED THE CONSUMER' BREATHING WAS STRANGE AND HE WAS UNRESPONSIVE WHEN SHE TRIED TO WAKE HIM. THE EMTS WERE CALLED AND WHEN THEY ARRIVED AT APPROXIMATELY AT 5:00AM THEY TESTED THE CONSUMER GETTING A RESULT OF 10 MG/DL ON THEIR GLUCOSE METER. THE CONSUMER WAS TREATED WITH GLUCOSE VIA IV FLUIDS, AND DECLINED TREATMENT AT THE HOSPITAL. DURING THE CALL TO CUSTOMER SUPPORT, IT WAS REVEALED THAT THE CONSUMER DOES NOT CONTROL SOLUTION TEST THEIR TEST STRIPS BEFORE USE AS INSTRUCTED IN OUR DIRECTIONS FOR USE. IT WAS ALSO REPORTED THAT THE CONSUMER IMPROPERLY STORES THEIR TEST STRIPS . THE CONSUMER WAS EDUCATED ON THESE DIRECTIONS FOR USE AT THE TIME OF CALL. THE TEST STRIPS IN QUESTION WILL NOT BE RETURNED FOR EVALUATION AS THE CONSUMER COMPLETED THE VIAL, HOWEVER, HE WILL RETURN A SECOND VIAL WITH THE SAME LOT NUMBER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NOVAMAX LINK GLUCOSE MONITOR GLUCOSE MONITOR NBW NOVA BIOMEDICAL CORP. NA 1020208091

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK