BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BACT/ALERT I FA PLUS

    MDR report key: 12274423 · Received August 4, 2021

    Report

    Report Number
    3002769706-2021-00034
    Event Type
    Malfunction
    Date Received
    August 4, 2021
    Report Date
    May 2, 2022
    Manufacturer
    BIOMERIEUX INC.
    Product Code
    MDB
    PMA / PMN Number
    K121461
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONTEXT: A CUSTOMER IN THE UNITED STATES NOTIFIED BIOMÉRIEUX OF AN INCREASED TIME TO DETECTION (TTD) OF ASPERGILLUS BRASILIENSIS, ATCC¿ 16404¿, (MICROBIOLOGICS #0392A, LOT 392-1088) DURING QUALITY CONTROL TESTS WHEN USING THE BACT/ALERT I FA PLUS (REFERENCE 412990, LOT#0004100061) IN ASSOCIATION WITH BACT/ALERT 3D SYSTEM. INVESTIGATION: BATCH HISTORY RECORD AND COMPLAINT TREND ANALYSIS: THERE IS NO CAPA RELATED TO THE CUSTOMER¿S COMPLAINT RECORDED. A COMPLAINT HISTORY REVIEW FOR THIS ISSUE CONCLUDED WITH NO IMPLICATION OF A TREND. THIS COMPLAINT HAS NOT BEEN IDENTIFIED AS A SYSTEMIC QUALITY ISSUE. INVESTIGATION RESULTS: RETAINED BOTTLES WERE OBTAINED FOR TESTING AND AN IN-HOUSE SEEDED STUDY WAS PERFORMED USING FOUR (4) DIFFERENT STRAIN SOURCES OF ASPERGILLUS BRASILIENSIS ATCC® 16404 WITH LESS THAN 100 CFU/BOTTLE IN IFA PLUS AND ILYM CULTURE BOTTLES: 1. MICROBIOLOGICS® EZ ACCU SHOT, 2. QUANTI-CULT¿ REMEL/THERMOFISHER¿, 3. BIOBALL®, 4. FRESH SPORE SUSPENSION. OLDER LOT AND NEWER LOTS WITH DIFFERENT MEDIA FORMULATIONS WERE TESTED FOR THE IFA PLUS BOTTLES AND BOTH PERFORMED THE SAME. SUMMARY OF TESTING CONCLUSION: IN-HOUSE TESTING WAS PERFORMED WITH ASPERGILLUS BRASILIENSIS SOURCED FROM MICROBIOLOGICS® EZ ACCUSHOT LYOPHILIZED PREPARATION AND QUANTI-CULT¿ REMEL/THERMOFISHER¿. TESTING WITH ASPERGILLUS BRASILIENSIS BIOBALL®, IFA PLUS BOTTLES WERE POSITIVE WITHIN 5 DAYS AT 32.5°C (MEETING BIOMÉRIEUX¿S QC RELEASE CRITERIA). FRESH SPORE SUSPENSIONS ALSO PERFORMED AS EXPECTED. GROWTH PERFORMANCE PERFORMED BEST IN THE ILYM BOTTLE. THE AUTHOR NOTED: CURRENTLY, ILYM IS MARKETED TO FOOD AND BEVERAGE CUSTOMERS. PHARMACEUTICAL AND/OR COSMETIC CUSTOMERS WHO WISH TO USE ILYM WOULD HAVE TO VALIDATE IT FOR THEIR SPECIFIC USE, AND WOULD NEED TO TAKE INTO CONSIDERATION THE FACT THAT THAT THE ILYM BOTTLE HAS NO NEUTRALIZATION CAPABILITY. ADDITIONAL STUDIES TO SUPPORT CUSTOMER VALIDATIONS MAY BE HELPFUL WITH FACILITATING THE ADDITION OF ILYM AS AN ADJUNCT TO THE IFA PLUS BOTTLE FOR THE DETECTION OF ASPERGILLUS BRASILIENSIS AND OTHER FUNGI. VARIABLES OF NEEDLE SIZE AND HEADSPACE VENTING WERE ALSO TESTED, WITH NO CORRELATION FOUND FOR GROWTH PERFORMANCE. THE BACT/ALERT IFA PLUS (NEW VERSION AND OLD VERSION LOTS) AND ILYM CULTURE BOTTLES PERFORMED AS EXPECTED, AND NO MALFUNCTION WAS FOUND. THE INVESTIGATION USED THE FIVE WHY¿S ROOT CAUSE ANALYSIS TOOL. THE MOST LIKELY ROOT CAUSE WAS THAT THE STRAIN FROM MICROBIOLOGICS® OR THERMOFISHER WAS NOT HEALTHY AND LED TO VARIABLE PERFORMANCE. THIS ROOT CAUSE WAS SUPPORTED BY THE IN-HOUSE TESTING DESCRIBED ABOVE. THE INSTRUCTIONS FOR USE (IFU) WERE REVIEWED AND FOUND TO BE ADEQUATE WITH NO REVISIONS ARE NEEDED. THE IFU CONTAINS A CAUTION: ON RARE OCCASIONS, ORGANISMS MAY BE ENCOUNTERED THAT GROW IN THE BACT/ALERT ® I FA PLUS CULTURE BOTTLE GROWTH MEDIUM BUT DO NOT PRODUCE SUFFICIENT CARBON DIOXIDE TO BE DETERMINED POSITIVE. AT MAXIMUM TEST TIME THE BOTTLE SHOULD BE VISUALLY INSPECTED FOR EVIDENCE OF GROWTH. THE IFA PLUS IFU HAS A LIMITATION OF TEST THAT STATES: CERTAIN SPECIES OF PENICILLIUM, ASPERGILLUS, OR OTHER TEMPERATURE SENSITIVE MOLDS MAY NOT GROW, OR MAY GROW BUT DO NOT PRODUCE SUFFICIENT CO2 TO BE DETERMINED POSITIVE. CONCLUSION: THE INVESTIGATION DID NOT FIND THAT THE BACT/ALERT BOTTLE LOT OR THE BACT/ALERT 3D INSTRUMENT WERE LIKELY ROOT CAUSES FOR THE COMPLAINT ISSUE. THE ROOT CAUSE ANALYSIS AND IN-HOUSE TESTING PERFORMED SHOWED THE MOST LIKELY ROOT CAUSE FOR THE VARIABLE PERFORMANCE WAS THE STRAIN SOURCE AND INCUBATION TEMPERATURE. THE BEST PERFORMANCE FOR THE SEEDED STUDY WAS WITH A BIOBALL STRAIN OR FRESH SPORE SUSPENSION INOCULATED INTO IFA PLUS CULTURE BOTTLES AND TESTED AT 32.5° C. ASPERGILLUS BRASILIENSIS FLAGGED POSITIVE IN LESS THAN 5 DAYS, WITH AN AVERAGE TIME TO DETECTION IN THE STUDY OF 2.11 DAYS IN IFA PLUS WITH BIOBALL.

    Description of Event or Problem · 1

    INTENDED USE. BACT/ALERT® I FA PLUS CULTURE BOTTLES ARE USED WITH THE BACT/ALERT® MICROBIAL DETECTION SYSTEM IN QUALITATIVE PROCEDURES FOR ENHANCED RECOVERY AND DETECTION OF AEROBIC AND FACULTATIVE MICROORGANISMS (BACTERIA AND FUNGI). THE LABORATORY IS RESPONSIBLE FOR VALIDATING THE BACT/ALERT® SYSTEM AND CULTURE BOTTLES FOR THEIR TESTING PURPOSES. IFA PLUS BOTTLES, REF (B)(4), ARE USED FOR INDUSTRIAL APPLICATION. HOWEVER, A SIMILAR CLINICAL PRODUCT IS THE FA PLUS BOTTLE, REFERENCE (B)(4). DESCRIPTION OF THE ISSUE: A CUSTOMER IN THE UNITED STATES NOTIFIED BIOMÉRIEUX OF AN INCREASED TIME TO DETECTION (TTD) OF ASPERGILLUS BRASILIENSIS, ATCC¿ 16404¿, (MICROBIOLOGICS #0392A, LOT 392-1088) DURING QUALITY CONTROL TESTS WHEN USING THE BACT/ALERT I FA PLUS (REFERENCE (B)(4), LOT# 0004100061) IN ASSOCIATION WITH BACT/ALERT 3D SYSTEM. THE CUSTOMER OBTAINED FOR BOTH INITIAL AND REPEAT TESTING A TTD OF FIFTEEN (15) DAYS, WHILE THE EXPECTED/TYPICAL TTD IS WITHIN FIVE (5) DAYS. AS THIS COMPLAINT CONCERNS QUALITY CONTROL TESTS, NO PATIENT IMPACT HAS BEEN REPORTED AS A CONSEQUENCE OF THE INCREASED TIME TO DETECTION. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1170048 BACT/ALERT I FA PLUS BACT/ALERT I FA PLUS MDB BIOMERIEUX INC. 0004100061

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown