BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BACT/ALERT MP BLOOD CULTURE BOTTLE

    MDR report key: 1106975 · Received August 7, 2008

    Report

    Report Number
    3002769706-2008-00004
    Event Type
    Malfunction
    Date Received
    August 7, 2008
    Date of Event
    May 22, 2008
    Report Date
    August 8, 2008
    Manufacturer
    BIOMERIEUX, INC.
    Product Code
    JTA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION HAS BEEN OPENED ON THIS MDR. CUSTOMER WAS CONTACTED WITH INSTRUCTIONS ON HOW TO VERIFY THE ALGORITHMS AND TO SET THE CORRECT ALGORITHMS FOR PLASTIC BOTTLES. GLOBAL CUSTOMER SERVICE ALSO RESENT THE FIELD CORRECTIVE ACTION/AMENDMENT WHICH HAD ADDRESSED THE ISSUE IN THE PAST. IT IS NOT KNOWN WHEN, OR BY WHOM, THE CHANGES IN THE SETTINGS WERE MADE. NECESSARY MEDICAL TREATMENT WAS NOT DELAYED OR WITHHELD BECAUSE OF THE TEST RESULT FROM THE INSTRUMENT. USER'S DATABASE WAS REVIEWED. RESULTS AND CONCLUSIONS: ALGORITHMS PARAMETERS INCORRECTLY MODIFIED, CAUSING INCORRECT READINGS.

    Description of Event or Problem · 1

    BASED ON INFORMATION SUPPLIED INITIALLY, THIS COMPLAINT OF A FALSE NEGATIVE WAS DETERMINED TO BE NOT REPORTABLE. VISUAL EXAMINATION OF THE BOTTLES INDICATED TURBIDITY AND GROWTH. THE LOWERNSTEIN-JENSEN SLANTS CONFIRMED THE SAMPLES WERE POSITIVE. UPON FURTHER INVESTIGATION INITIATED BY BIOMERIEUX, INC., A DIFFERENT ISSUE EMERGED CONCERNING THE ALGORITHMS USED. THIS INCIDENT IS NOW DETERMINED TO BE REPORTABLE. FOLLOWING REVIEW OF THE USER'S DATABASE, IT WAS DETERMINED THAT BOTTLES BARCODE CONFIGURATION PARAMETERS HAD BEEN MODIFIED SO THAT ALGORITHMS WERE ASSIGNED TO THE BACT/ALERT BLOOD CULTURE BOTTLE THAT DO NOT CONFORM TO THE CURRENT ALGORITHM IMPLEMENTATION FOR BACT/ALERT PLASTIC BOTTLES. ALSO, A MODIFICATION WAS MADE FOR THE BARCODE PREFIX, PROBABLY TO FACILITATE THE USE OF BARCODES OTHER THAN THOSE SUPPLIED BY BIOMERIEUX. INCORRECT ALGORITHMS MAY RESULT IN INCORRECT RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BACT/ALERT MP BLOOD CULTURE BOTTLE MICROBIAL GROWTH MONITOR JTA BIOMERIEUX, INC. 1017261

    Patients

    Seq Age Sex Outcome Treatment
    1