BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LOGIC BLOOD GLUCOSE MONITOR

    MDR report key: 4163353 · Received July 16, 2014

    Report

    Report Number
    3004193489-2014-00057
    Event Type
    Malfunction
    Date Received
    July 16, 2014
    Date of Event
    June 30, 2014
    Report Date
    June 30, 2014
    Manufacturer
    NOVA BIOMEDICAL CORP
    Product Code
    CGA
    PMA / PMN Number
    K041478
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, 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'S BLOOD GLUCOSE METER SWITCHED UNITS OF MEASURE FROM MG/DL TO MMOL/DL. THE METER IN QUESTION WILL BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    416920 BD LOGIC BLOOD GLUCOSE MONITOR GLUCOSE MONITOR CGA NOVA BIOMEDICAL CORP NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK