BEUDAMED
    FDA Adverse Event Other Summary report: N

    NOVA MAX GLUCOSE MONITOR

    MDR report key: 1884174 · Received October 15, 2010

    Report

    Report Number
    3004193489-2010-00233
    Event Type
    Other
    Date Received
    October 15, 2010
    Date of Event
    October 1, 2010
    Report Date
    October 15, 2010
    Manufacturer
    NOVA BIOMEDICAL CORPORATION
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, 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 THAT A CONSUMER RECEIVED A RESULT OF 531 MG/DL ON THEIR BLOOD GLUCOSE METER. THE CONSUMER ADMITTED THAT SHE ADMINISTERED AN UNK AMOUNT AND A DOUBLE DOSE OF HER DIABETES MEDICATION. CONSUMER BEGAN SLURRING HER WORDS WHILE ON THE PHONE, AND CLAIMED THAT HER MOM WAS WITH HER. THE CONSUMER REFUSED MEDICAL ASSISTANCE WHEN THE CUSTOMER SUPPORT REP OFFERED TO CALL FOR EMERGENCY SERVICES. DURING THE CALL TO CUSTOMER SUPPORT, IT WAS REVEALED THAT THE CONSUMER HAS NEVER PERFORMED A CONTROL SOLUTION TEST ON TEST STRIPS TO CHECK THEIR INTEGRITY BEFORE USE AS INSTRUCTED IN OUR DIRECTIONS FOR USE. 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
    1 NOVA MAX GLUCOSE MONITOR GLUCOSE MONITOR NBW NOVA BIOMEDICAL CORPORATION NA 1020210041

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention