BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BACT/ALERT® FA PLUS CULTURE BOTTLE

    MDR report key: 5235588 · Received November 19, 2015

    Report

    Report Number
    3002769706-2015-00148
    Event Type
    Malfunction
    Date Received
    November 19, 2015
    Report Date
    November 12, 2015
    Manufacturer
    BIOMERIEUX, INC
    Product Code
    MDB
    PMA / PMN Number
    K121461
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INVESTIGATION WAS INITIATED TO INVESTIGATE A DISCREPANT RESULT WHEN AN ATCC SAMPLE WAS SPIKED INTO A BACT/ALERT® FA PLUS CULTURE BOTTLE. THE CUSTOMER REPORTED THAT THEY INOCULATED FA PLUS BOTTLES FROM LOT 3041653, WITH 9 ML DIRECT DRAW HUMAN BLOOD (DONOR WAS NOT ON ANTIMICROBIAL THERAPY) AND STENOTROPHOMONAS MALTOPHILIA, ATCC STRAIN 17666, ON THREE SEPARATE DATES. BOTTLES WERE LOADED INTO A BACT/ALERT® 3D, AND WERE DECLARED NEGATIVE AFTER 5 DAYS. EACH OF THE THREE BOTTLES WAS SUBCULTURED TO SOLID MEDIUM, AND EACH SHOWED GROWTH ON THE PLATE. IT IS IMPORTANT TO NOTE THE CUSTOMER STATED THAT UPON PLATING THE INOCULUM, ONLY 1-2 COLONIES GREW PER PLATE. THE INVESTIGATION EXAMINED THE BACT/ALERT® FA PLUS LOT 3041653 QUALITY CONTROL RELEASE TESTING AND RECORDS, AND ALL THE RESULTS WERE ACCEPTABLE. EACH LOT OF FA PLUS UNDERGOES GROWTH PERFORMANCE TESTING WITH AEROBIC AND ANAEROBIC ORGANISMS, INCLUDING S. MALTOPHILIA (ATCC 13637). THE BACT/ALERT® FA PLUS IFU, 9305048 C, WAS REVIEWED. IN THE THIRD NOTE UNDER THE BOTTLE PREPARATION SECTION, THE USER IS CAUTIONED THAT "ALTHOUGH LOWER SAMPLE VOLUMES CAN BE USED, RECOVERY MAY BE IMPROVED USING A SAMPLE VOLUME AS RECOMMENDED, 10 ML." THE LABORATORY PROCEDURE STATES "NEGATIVE BOTTLES MAY BE CHECKED BY SMEAR AND/OR SUBCULTURE AT SOME POINT PRIOR TO DISCARDING AS NEGATIVE." THE IFU PROVIDED SUFFICIENT INSTRUCTIONS TO THE USERS FOR HANDLING OF NEGATIVE BOTTLES. DURING VALIDATION OF THE BACT/ALERT® FA PLUS BOTTLE, SIX STRAINS OF S. MALTOPHILIA WERE TESTED WITH FOUR SEPARATE VOLUMES OF HUMAN BLOOD, AND ALL BOTTLES FLAGGED POSITIVE. ONE STRAIN OF S. MALTOPHILIA, ATCC 13637, WAS TESTED THROUGHOUT THE SHELF LIFE STUDY AND BOTTLES FLAGGED POSITIVE, AS EXPECTED. THE MOST PROBABLE ROOT CAUSE OF THE OBSERVED FALSE NEGATIVE RESULTS IS BELIEVED TO BE DUE TO AN UNHEALTHY QC ORGANISM CULTURE INOCULATED INTO THE BOTTLES. THE CUSTOMER STATED ON THAT ANOTHER STRAIN OF S. MALTOPHILIA WAS TESTED IN THE BACT/ALERT® FA PLUS BOTTLES AND ALL BOTTLES FLAGGED POSITIVE IN "ABOUT 24 HOURS". THE CUSTOMER STATED THAT THE LIKELY CAUSE OF THE REPORTED FAILURES WAS THAT THE ORIGINAL QC STRAIN THAT WAS TESTED WAS VERY WEAK BECAUSE IT TOOK 2 DAYS TO GROW ON A PLATE. THE BIOMERIEUX INVESTIGATION TEAM MEMBERS ARE IN AGREEMENT WITH THIS CONCLUSION.

    Description of Event or Problem · 1

    ON (B)(6) 2015, A CUSTOMER CONTACTED BIOMERIEUX TO REPORT A DISCREPANT RESULT ASSOCIATED WITH A BACT/ALERT® FA PLUS CULTURE BOTTLE QC SAMPLE. THE CUSTOMER INOCULATED THE CULTURE BOTTLE WITH A KNOWN SAMPLE OF STENOTROPHOMONAS MALTOPHILA (ATCC® 17666) AS PART OF AN INTERNAL SEEDED STUDY. THE CULTURE BOTTLE HAD A FINAL DETERMINATION OF NEGATIVE; HOWEVER UPON TERMINAL SUBCULTURE, THE RESULT WAS POSITIVE. AN INTERNAL INVESTIGATION HAS BEEN INITIATED BY BIOMERIEUX TO DETERMINE THE CAUSE OF THIS DISCREPANT RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    767833 BACT/ALERT® FA PLUS CULTURE BOTTLE BACT/ALERT® FA PLUS CULTURE BOTTLE MDB BIOMERIEUX, INC 3041653

    Patients

    Seq Age Sex Outcome Treatment
    1