BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHROMID C. DIFFICILE AGAR

    MDR report key: 7334715 · Received March 13, 2018

    Report

    Report Number
    3002769706-2018-00036
    Event Type
    Malfunction
    Date Received
    March 13, 2018
    Report Date
    May 18, 2018
    Manufacturer
    BIOMERIEUX SPAIN
    Product Code
    JSI
    UDI-DI
    03573026316969
    PMA / PMN Number
    C1 EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    A CUSTOMER IN GERMANY REPORTED A RESULT OF NO GROWTH, FOR A CLOSTRIDIUM DIFFICILE QUALITY CONTROL (QC) STRAIN (ATCC 9689), IN ASSOCIATION WITH CHROMID¿ C. DIFFICILE AGAR. AN INTERNAL BIOMÉRIEUX INVESTIGATION WAS PERFORMED. THIS INVESTIGATION CONSISTED OF A REVIEW OF QUALITY RECORDS ASSOCIATED WITH THE IMPACTED LOT NUMBER AND AN ANALYSIS OF BIOMÉRIEUX RETAINED SAMPLE PLATES WITH BIOMÉRIEUX QUALITY CONTROL STRAINS, INCLUDING CLOSTRIDIUM DIFFICILE ATCC 9689. TESTING WAS PERFORMED ON BIOMÉRIEUX RETAINED SAMPLE PLATES WITH BIOMÉRIEUX QUALITY CONTROL STRAINS, INCLUDING CLOSTRIDIUM DIFFICILE ATCC 9689. ANALYSIS WAS PERFORMED ON BIOMÉRIEUX RETAINED SAMPLE PLATES FOR THE IMPACTED LOT NUMBER AND ON TWO (2) REFERENCE LOTS (LOTS 1006307020 AND 1006136670). TESTING WAS PERFORMED IN ORDER TO CONTROL THE MICROBIOLOGICAL PERFORMANCE OF THE IMPACTED LOT NUMBER 1006170510 WITH FIVE (5) CLOSTRIDIUM DIFFICILE STRAINS INCLUDING THE CUSTOMER IMPACTED STRAIN (ATCC BAA-215, ATCC BAA-2156, NRRL43101 0801090, 0801055 AND ATCC 9689). THREE (3) ADDITIONAL STRAINS (PSEUDOMONAS AERUGINOSA ATCC 9027, ENTEROCOCCUS FAECALIS ATCC 29212, AND CANDIDA TROPICALIS ATCC 9968) WERE TESTED TO VERIFY EXPECTED INHIBITION. THE FOLLOWING RESULTS WERE OBTAINED: GOOD GROWTH WITH CHARACTERISTIC COLOUR WAS OBTAINED FOR THE FIVE (5) CLOSTRIDIUM DIFFICILE STRAINS INCLUDING ATCC9689 ON BOTH THE IMPACTED LOT 1006170510 AND ON THE REFERENCE LOT NUMBERS 1006307020 AND 1006136670, AFTER 24 HOURS OF INCUBATION AT 37°C. TOTAL INHIBITION WAS OBSERVED FOR PSEUDOMONAS AERUGINOSA ATCC 9027, ENTEROCOCCUS FAECALIS ATCC 29212 AND CANDIDA TROPICALIS ATCC 9968. IN CONCLUSION, TESTING ON THE RETAINED SAMPLE PLATES FOR THE IMPACTED LOT NUMBER INDICATED THAT THE PRODUCT IS PERFORMING WITHIN SPECIFICATION. THE ISSUE OBSERVED BY THE CUSTOMER WAS NOT CONFIRMED. A REVIEW OF QUALITY RECORDS CONFIRMED THERE WERE NO ISSUES ASSOCIATED WITH THE IMPACTED LOT. OF NOTE, C. DIFFICILE IS A STRICT ANAEROBE AND IS EXTREMELY SENSITIVE TO EVEN LOW CONCENTRATIONS OF OXYGEN IN THE ATMOSPHERE. THEREFORE, A CONTROLLED, ANAEROBIC ENVIRONMENT IS NEEDED FOR ITS SUCCESSFUL MANIPULATION. TO ENSURE GROWTH OF C. DIFFICILE STRAINS, EXPOSURE TO OXYGEN MUST BE LIMITED AS MUCH AS POSSIBLE WHEN PERFORMING THE BACTERIAL SUSPENSION AND THE INOCULATION STEPS. THE ANAEROBIC CONDITIONS DURING THE INCUBATION STEP MUST ALSO BE OPTIMAL TO ENSURE GROWTH OF THESE STRAINS.

    Description of Event or Problem · 1

    A CUSTOMER IN (B)(6) REPORTED A RESULT OF NO GROWTH, FOR A CLOSTRIDIUM DIFFICILE QUALITY CONTROL (QC) STRAIN (B)(4)), IN ASSOCIATION WITH CHROMID¿ C. DIFFICILE AGAR. THE CUSTOMER STATED THEY INOCULATED A NEW LOT OF CHROMID¿ C. DIFFICILE AGAR (LOT 1006170510) WITH THE QC STRAIN, AND HAD OBSERVED NO BACTERIAL GROWTH AFTER INCUBATION AT 36 °C (+/- 1°C) IN ANAEROBIC ATMOSPHERE (GENERATED BY ANAEROBIC JARS). THE CUSTOMER STATED THAT THEY PERFORM THE QC TEST FOR EACH NEW LOT, AND THAT CLINICAL SAMPLES WERE NOT INOCULATED ON THIS LOT. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    177655 CHROMID C. DIFFICILE AGAR CHROMID¿ C. DIFFICILE AGAR JSI BIOMERIEUX SPAIN 1006170510 03573026316969

    Patients

    Seq Age Sex Outcome Treatment
    1