BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BACT/ALERT® SN CULTURE BOTTLE

    MDR report key: 8195991 · Received December 26, 2018

    Report

    Report Number
    3002769706-2018-00256
    Event Type
    Malfunction
    Date Received
    December 26, 2018
    Report Date
    June 19, 2019
    Manufacturer
    BIOMERIEUX INC.
    Product Code
    MDB
    UDI-DI
    03573026055813
    PMA / PMN Number
    K021123
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    AN INTERNAL BIOMÉRIEUX INVESTIGATION WAS INITIATED FOR A CUSTOMER REPORT OF GROWTH PERFORMANCE ISSUES ASSOCIATED WITH BACT/ALERT® SN CULTURE BOTTLE (REFERENCE 259790). THE INVESTIGATION EXAMINED BACT/ALERT® SN LOT 1051203 AND BACT/ALERT® SN LOT 1051021 MANUFACTURING DIRECTIONS, INCLUDING THE QUALITY CONTROL RELEASE TESTING DOCUMENTATION, AND ALL RESULTS FOR EACH LOT WERE WITHIN SPECIFICATION. QUALITY ASSURANCE SUBSEQUENTLY RELEASED THE LOTS FOR DISTRIBUTION TO THE FIELD. HISTORICAL REVIEW OF COMPLAINT DATA FROM 01-NOV-2017 THROUGH 12-FEB-2019 DETERMINED THIS IS AN ISOLATED INCIDENT. THERE WERE NO OTHER SIMILAR COMPLAINTS ASSOCIATED WITH BACT/ALERT® SN LOT 1051021 OR BACT/ALERT® SN LOT 1051203. THE ROOT CAUSE COULD NOT BE DETERMINED BUT A STUDY PERFORMED BY BIOMÉRIEUX INVOLVING PREPARATIONS OF MICROBIOLOGICS® KWIK-STIK¿ CLOSTRIDIUM SPOROGENES ATCC® 19404 LYOPHILIZED STRAIN PRODUCT TESTED WITH BACT/ALERT® SN LOT 1051021 AND BACT/ALERT® SN LOT 1051203 BOTTLES RECOVERED CLOSTRIDIUM SPOROGENES AT BOTH 32.5 °C AND 36 °C. THE BACT/ALERT® 3D INSTRUMENT FLAGGED THE BOTTLES POSITIVE BETWEEN 18.0 AND 35.8 HOURS THE BACT/ALERT® SN PRODUCT IS NOT INTENDED FOR USE WITH INDUSTRY APPLICATIONS AND SAMPLES. THE BACT/ALERT® INST BOTTLE WOULD BE THE CORRECT BOTTLE TO USE FOR STEM CELL TESTING.

    Description of Event or Problem · 1

    A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF GROWTH PERFORMANCE ISSUE ASSOCIATED WITH BACT/ALERT® SN CULTURE BOTTLE (REFERENCE 259790). THE CUSTOMER REPORTED DURING THE BATCH ACCEPTANCE PROCEDURE USED TO ESTABLISH THE STERILITY OF STEM CELLS USED FOR TRANSPLANT PER THE EUROPEAN PHARMACOPEIA GUIDELINES 2011 VOLUME V METHOD 2.6.27 ONE OF THE ORGANISMS RECOMMENDED BY THIS METHOD, CLOSTRIDIUM SPOROGENES ATCC 19404, FAILED TO GROW IN AN INOCULATED BOTTLE WITH CONCENTRATION OF ORGANISM AT 10-5. A COLUMBIA BLOOD AGER PLATE INOCULATED WITH THE SAME SUSPENSION GREW 45 COLONIES ON OVERNIGHT INCUBATION IN ANAEROBIC CONDITIONS. A SUSPENSION OF BACTEROIDES FRAGILIS ATCC 25285 AT A CONCENTRATION OF 10-6 GREW SUCCESSFULLY IN THE BOTTLES. ALTHOUGH NOT NORMALLY USED IN THE PROCEDURE, THE CUSTOMER USED A STRAIN OF CLOSTRIDIUM PERFRINGENS ATCC 19401 WHICH SUCCESSFULLY GREW IN THE BOTTLES. THE CUSTOMER ATTEMPTED THE PROCEDURE AGAIN USING A NEW LOT NUMBER OF BOTTLES (1051203) BUT AGAIN THE CLOSTRIDIUM SPOROGENES ATCC 19404 FAILED TO GROW AT A CONCENTRATION OF 10-5 AND ALSO AT A CONCENTRATION OF 10-4. A NEW STRAIN OF ORGANISM FROM A LYOPHILIZED CULTURE (RECONSTITUTED PER MANUFACTURING GUIDELINES) WAS ALSO ATTEMPTED BUT THIS TOO FAILED TO GROW. A SUBCULTURE OF THE BOTTLES AFTER SEVEN (7) DAYS OF INCUBATION FAILED TO RECOVER VIABLE ORGANISMS. THERE IS NO INDICATION OR REPORT FROM THE LABORATORY OR PHYSICIAN THAT THE DISCREPANT RESULT LED TO ANY ADVERSE EVENT RELATED TO A PATIENT'S STATE OF HEALTH. AN INTERNAL BIOMÉRIEUX INVESTIGATION WILL BE INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1034458 BACT/ALERT® SN CULTURE BOTTLE BACT/ALERT® SN CULTURE BOTTLE MDB BIOMERIEUX INC. 1051203 03573026055813

    Patients

    Seq Age Sex Outcome Treatment
    1