BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHROMID® S AUREUS AGAR

    MDR report key: 5667095 · Received May 19, 2016

    Report

    Report Number
    3002769706-2016-00090
    Event Type
    Malfunction
    Date Received
    May 19, 2016
    Report Date
    May 12, 2016
    Manufacturer
    BIOMERIEUX SA
    Product Code
    JWX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF A DISCREPANT RESULT ASSOCIATED WITH CHROMID S. AUREUS AGAR (REFERENCE 43371) INVOLVING ABSENCE OF GROWTH FOR A S. AUREUS STRAIN AFTER 48 HOURS OF INCUBATION. AN INTERNAL BIOMÉRIEUX INVESTIGATION WAS PERFORMED WITH RESULTS AS FOLLOWS: RETENTION SAMPLE OF CUSTOMER'S LOT (1004624450) AND TWO RANDOM LOTS (1004639390/SAME MANUFACTURING DATE AND 1004875030/RECENT MANUFACTURE DATE) WERE TESTED WITH STRAINS S. AUREUS ATCC 25923, S. AUREUS ATCC 6538, S. XYLOSUS ATCC 29971 AND S. SAPROPHYTICUS ATCC 15305. RESULTS- AFTER 18-24 HOUR INCUBATION AT 33-37° C, THE PERFORMANCE WAS WITHIN SPECIFICATIONS FOR ALL STRAINS WITHOUT DIFFERENCES BETWEEN LOTS REGARDING: NUMERATION, SIZE OF COLONY AND INTENSITY OF COLOR. S. AUREUS ATCC 25923 AND S. AUREUS ATCC 6538 PRODUCED THE EXPECTED COLONY APPEARANCE. BOTH DEVELOPED A SPONTANEOUS GREEN COLORATION WHEREAS, S. XYLOSUS ATCC 29971 AND S. SAPROPHYTICUS ATCC 15305 WERE NOT ABLE TO PRODUCE GLUCOSIDASE ACTIVITY. COMPLAINT TRENDING WAS REVIEWED; NO CRITICAL ISSUES REGARDING PRODUCT PERFORMANCE WERE DETECTED. REVIEW OF RAW DATA RELATED TO MANUFACTURING PROCESS AND QUALITY CONTROL STEPS WAS PERFORMED. ALL SPECIFICATIONS MET AND NO OBSERVATIONS OR NON-CONFORMITIES FOUND THAT COULD EXPLAIN THE PERFORMANCE PROBLEM REPORTED BY THE CUSTOMER. BIOMÉRIEUX REQUESTED THE STRAIN FROM THE CUSTOMER; HOWEVER, IT WAS NOT POSSIBLE TO SUBMIT THE STRAIN. BASED UPON THE RESULTS OF THE INTERNAL INVESTIGATION, CHROMID S. AUREUS AGAR IS PERFORMING IN ACCORDANCE WITH PRODUCT SPECIFICATIONS.

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    A CUSTOMER IN FRANCE NOTIFIED BIOMÉRIEUX OF A DISCREPANT RESULT ASSOCIATED WITH CHROMID® S. AUREUS AGAR (REFERENCE (B)(4)). THE CUSTOMER REPORTED AN ABSENCE OF GROWTH FOR A S. AUREUS STRAIN AFTER 48 HOURS OF INCUBATION. THE STRAIN WAS ISOLATED ON COS ANC MEDIA. THE CUSTOMER INDICATED THAT THE FALSE RESULT WAS NOT REPORTED TO A PHYSICIAN; HOWEVER, THE RESULT WAS DELAYED FOR 24 HOURS. AN INTERNAL BIOMÉRIEUX INVESTIGATION WILL BE INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    322504 CHROMID® S AUREUS AGAR CHROMID® S AUREUS AGAR JWX BIOMERIEUX SA 1004624450

    Patients

    Seq Age Sex Outcome Treatment
    1