BEUDAMED
    FDA Adverse Event Other Summary report: N

    NOVA MAX GLUCOSE MONITOR

    MDR report key: 1220243 · Received October 31, 2008

    Report

    Report Number
    3004193489-2008-00606
    Event Type
    Other
    Date Received
    October 31, 2008
    Date of Event
    October 16, 2008
    Report Date
    October 31, 2008
    Manufacturer
    NOVA BIOMEDICAL CORP.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, 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 F/U REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO NOVA BIOMEDICAL THAT A CONSUMER EXPERIENCED A HYPOGLYCEMIC EVENT, REQUIRING MEDICAL INTERVENTION. DURING THE CALL TO THE CUSTOMER CARE DEPT, IT WAS REVEALED THAT THE CONSUMER IMPROPERLY STORES THEIR TEST STRIPS AND, THE CONSUMER DOES NOT CONTROL SOLUTION TEST BEFORE USE, AS INSTRUCTED IN OUR DIRECT EDUCATION, TOOK PLACE AT THE TIME OF CALL. THE TEST STRIPS IN QUESTION WILL BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NOVA MAX GLUCOSE MONITOR GLUCOSE MONITOR NBW NOVA BIOMEDICAL CORP. NA 1020208007

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK