BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BACT/ALERT® FA PLUS

    MDR report key: 8292565 · Received January 31, 2019

    Report

    Report Number
    3002769706-2019-00003
    Event Type
    Malfunction
    Date Received
    January 31, 2019
    Report Date
    November 21, 2019
    Manufacturer
    BIOMERIEUX INC.
    Product Code
    MDB
    PMA / PMN Number
    K121461
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    AN INTERNAL BIOMÉRIEUX INVESTIGATION WAS INITIATED FOLLOWING A CUSTOMER REPORT OF A FALSE NEGATIVE RESULT (NO GROWTH IN THE BOTTLE) FOR AN ASPERGILLUS BRASILIENSIS ATCC 16404 QUALITY CONTROL STRAIN IN ASSOCIATION WITH THE BACT/ALERT® IFA PLUS BOTTLE (REFERENCE (B)(4), LOT 4051563) WHILE PERFORMING A SEEDED STUDY. THE INVESTIGATION EXAMINED IFA PLUS LOT 4051563 MANUFACTURING DIRECTIONS, INCLUDING THE QUALITY CONTROL RELEASE TESTING DOCUMENTATION, AND ALL RESULTS FOR WERE FOUND TO BE WITHIN SPECIFICATION. QUALITY ASSURANCE SUBSEQUENTLY RELEASED THE LOTS FOR DISTRIBUTION TO THE FIELD. HISTORICAL REVIEW OF COMPLAINT DATA FROM 01JAN18 THROUGH 15OCT19 DETERMINED THIS IS AN ISOLATED INCIDENT. THERE WERE NO OTHER SIMILAR COMPLAINTS ASSOCIATED WITH BACT/ALERT® IFA PLUS LOT 4051563. REVIEW OF THE CERTIFICATE OF CONFORMANCE [COC] FOR IFA PLUS LOT 4051563 REVEALED SAMPLES OF THE LOT WERE TESTED USING STANDARD PROCEDURES WHICH INCLUDE THE METHODS AND CONTROL ATCC CULTURES SPECIFIED IN "QUALITY CONTROL FOR COMMERCIALLY PREPARED MICROBIOLOGICAL CULTURE MEDIA" (CLSI APPROVED STANDARD). ADDITIONALLY, SATISFACTORY GROWTH WAS EXHIBITED FOR ASPERGILLUS BRASILIENSIS NCPF 2275. UPON COMPLETION OF REVIEW OF COMPLAINT TEXT, INSTRUCTIONS FOR USE [IFU] AND COC THE FOLLOWING TWO PROBABLE ROOT CAUSES WERE IDENTIFIED: IT IS PROBABLE THAT A SAMPLING ERROR OCCURRED IN THAT THE ORGANISM WAS OVERDILUTED AND/OR THE BOTTLE WAS NOT INCUBATED LONG ENOUGH. AT LOW VOLUMES AND LOW INOCULATION LEVELS, IT COULD TAKE LONGER THAN THE FIVE (5) INCUBATION DAYS USED AT THE CUSTOMER SITE TO PRODUCE A POSITIVE TEST RESULT. AS DOCUMENTED IN THE IFA PLUS IFU, A KNOWN LIMITATION OF THE TEST IS THAT MOLDS MAY NOT GROW OR MAY GROW BUT DO NOT PRODUCE SUFFICIENT CO2 TO BE FLAGGED AS POSITIVE. THIS COULD BE INHERENT TO THE PROCESS WHEN INOCULATING LOW VOLUMES (100 UL). BIOMERIEUX CAUTIONS THE ENDS USER TO BE AWARE WITH LOW VOLUME AND LOW INOCULATION LEVELS, SAMPLING ERRORS COULD OCCUR. AS SUCH, REVIEW OF SITE METHODS FOR INCUBATION TIME IS ENCOURAGED. THERE WAS NOT ENOUGH INFORMATION PROVIDED FOR EVALUATION OF THE COMPLAINT, SUCH AS BOTTLE GRAPHS AND AN INSTRUMENT BACKUP. IT IS POSSIBLE THE ASPERGILLUS WAS GROWING TOO SLOWLY FOR DETECTION AT THE INCUBATION TEMPERATURE CHOSEN BY THE CUSTOMER. THE USER CAN READ THE IFA PLUS BOTTLES VISUALLY BEFORE DISCARDING BOTTLES AS NEGATIVE, AS FILAMENTOUS FUNGI OFTEN GROW IN FUNGAL BALLS IN BROTH.

    Description of Event or Problem · 1

    A CUSTOMER IN (B)(6) REPORTED A FALSE NEGATIVE RESULT FOR AN ASPERGILLUS BRASILIENSIS (ATCC16404) QUALITY CONTROL STRAIN IN ASSOCIATION WITH THE BACT/ALERT® FA PLUS BOTTLE (REFERENCE 412990). THE CUSTOMER WAS PERFORMING QC ON A NEW LOT NUMBER (4051563) FOR A SEEDED STUDY TEST. THE CUSTOMER REPORTED WHILE THE BOTTLE HAD NO GROWTH OF THE ORGANISM, A PARALLEL PLATE SHOWED GROWTH, AND COLONIES WERE DETECTED. THE CUSTOMER MAKES THE SERIAL DILUTION AND PLATE WITH A KNOWN CONCENTRATION OF 10-100 CFU, AND ABOUT 100¿L WAS INJECTED INTO THE BOTTLE. THE PLATE WAS INCUBATED FOR 5 DAYS AT 20/25°C. THERE WAS NO PATIENT INVOLVEMENT AS THE EVENT PERTAINED TO A QUALITY CONTROL SAMPLE. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    86446 BACT/ALERT® FA PLUS BACT/ALERT® FA PLUS MDB BIOMERIEUX INC. 4051563

    Patients

    Seq Age Sex Outcome Treatment
    1