BEUDAMED
    FDA Adverse Event Other Summary report: N

    BD LOGIC BLOOD GLUCOSE MONITOR

    MDR report key: 1083554 · Received July 25, 2008

    Report

    Report Number
    3004193489-2008-00517
    Event Type
    Other
    Date Received
    July 25, 2008
    Date of Event
    July 16, 2008
    Report Date
    July 24, 2008
    Manufacturer
    NOVA BIOMEDICAL CORP.
    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 FOR 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 35 MG/DL AND BASED ON THAT READING, THE CONSUMER WENT TO THE EMERGENCY ROOM TO HAVE THEIR BLOOD SUGAR LEVEL CHECKED. DURING THE CALL TO CUSTOMER SUPPORT, IT WAS REVEALED THAT THE TEST STRIPS THE CONSUMER IS USING EXPIRED SEPT 2007. THE CONSUMER ALSO ADMITTED THAT THEY DO NOT USE CONTROL SOLUTIONS TO TEST THEIR STRIPS AS INSTRUCTED IN OUR DIRECTIONS FOR USE. CONSUMER EDUCATED ON THESE DIRECTIONS FOR USE AT THE TIME OF CALL. THE METER IN QUESTION WILL BE RETURNED FOR EVALUATION. THE EXPIRED TEST STRIPS IN QUESTION HAVE BEEN DISCARDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK