BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BACT/ALERT MP (PLASTIC) - 259797

    MDR report key: 9330444 · Received November 15, 2019

    Report

    Report Number
    3002769706-2019-00061
    Event Type
    Malfunction
    Date Received
    November 15, 2019
    Report Date
    May 29, 2020
    Manufacturer
    BIOMÉRIEUX, INC.
    Product Code
    MDB
    PMA / PMN Number
    K031737
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT WAS INITIALLY SUBMITTED FOLLOWING NOTIFICATION FROM A CUSTOMER IN THE UNITED KINGDOM REGARDING FALSE NEGATIVE RESULTS WHILE TESTING A NEQAS SURVEY STRAIN OF MYCOBACTERIUM TUBERCULOSIS USING THE BACT/ALERT® MP BOTTLE (REF. (B)(4), LOT 1052586). A BIOMÉRIEUX INTERNAL INVESTIGATION WAS COMPLETED. THE FINAL PRODUCT TESTING MET THE SPECIFICATIONS AND PASSED QUALITY CONTROL AND GROWTH PERFORMANCE TESTING. M. TUBERCULOSIS PASSED GROWTH PERFORMANCE. THERE WERE NO INVALID RESULTS OR OUT OF SPECIFICATION RESULTS IN REGARD TO THE LOT. NO MANUFACTURING CAPA OR DEVIATIONS WERE DOCUMENTED FOR FILLING LOT 1052586. THE BACT/ALERT® MP INSTRUCTIONS FOR USE (IFU) REVIEW CONCLUDED THAT IT CONTAINED ADEQUATE DIRECTIONS AND NO REVISIONS WERE NEEDED. THE CUSTOMER DID NOT INDICATE IF THERE WAS PRESENCE OF THE PINK TINT IN THE BOTTLE AFTER ADDITION OF THE MB/BACT ANTIBIOTIC SUPPLEMENT, PRIOR TO INOCULATION. THE CUSTOMER DID NOT STATE IF THE BOTTLES WERE VISUALLY INSPECTED FOR TURBIDITY OR CONTENT WAS STAINED, AS DIRECTED BY THE IFU FOR NEGATIVE BOTTLES, NOR DID THEY SHARE THEIR PROCEDURE. THE ROOT CAUSE COULD NOT BE DETERMINED BASED ON THE INFORMATION PROVIDED BY THE CUSTOMER. THE LIKELY ROOT CAUSE FOR THE FALSE NEGATIVE RESULTS WAS THAT NON-VIABLE CELLS WERE INTRODUCED INTO THE BOTTLE. THE LACK OF INFORMATION PROVIDED BY THE CUSTOMER DOES NOT ALLOW FOR FURTHER EVALUATION. THE OTHER CHALLENGES IN THE SURVEY SET WERE PASSED BY THE CUSTOMER, AND TWO OF THESE ALSO INCLUDED M. TUBERCULOSIS. IT'S POSSIBLE THAT THE SIMULATED SAMPLE HAD A WEAK STRAIN OR LOW NUMBERS AND A HARSHER DECONTAMINATION REAGENT COULD HAVE CONTRIBUTED TO THE OUTCOME.SEE SECTION H10.

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    A CUSTOMER IN THE UNITED KINGDOM NOTIFIED BIOMÉRIEUX OF OBTAINING FALSE NEGATIVE RESULTS WHILE TESTING A NEQAS SURVEY STRAIN OF MYCOBACTERIUM TUBERCULOSIS USING THE BACT/ALERT® MP BOTTLE (REF. 259797, LOT 1052586). THE SAMPLE WAS TESTED TWICE; BOTH BOTTLE INOCULATIONS WERE NEGATIVE FOR GROWTH. AURAMINE PHENOL STAINING WAS PERFORMED ON THE SAMPLE PREPARATIONS WHICH WERE INOCULATED INTO EACH BOTTLE. THE AURAMINE PHENOL STAINING SHOWED PRESENCE OF ACID FAST BACILLI. AS THERE IS NO PATIENT ASSOCIATED WITH THIS QUALITY CONTROL STRAIN, THERE IS NO ADVERSE EVENT RELATED TO ANY PATIENT'S STATE OF HEALTH. BIOMÉRIEUX WILL INITIATE AN INTERNAL INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1121674 BACT/ALERT MP (PLASTIC) - 259797 BACT/ALERT MP (PLASTIC) - 259797 MDB BIOMÉRIEUX, INC. 1052586

    Patients

    Seq Age Sex Outcome Treatment
    1