BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BACT/ALERT I AST

    MDR report key: 15682411 · Received October 27, 2022

    Report

    Report Number
    3002769706-2022-00045
    Event Type
    Malfunction
    Date Received
    October 27, 2022
    Report Date
    March 2, 2023
    Manufacturer
    BIOMÉRIEUX, INC
    Product Code
    MDB
    PMA / PMN Number
    K020931
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 FALSE POSITIVE RESULTS WHERE NO ORGANISM WAS PRESENT IN ASSOCIATION WITH THE BACT/ALERT® IAST INDUSTRY CULTURE BOTTLE (REF. 259786, BATCH NUMBER 0001058342, EXPIRATION DATE 19-JAN-2023) WHILE TESTING CELL AND GENE THERAPY PRODUCTS. INVESTIGATION: BATCH RECORD REVIEW AND TREND REVIEW: THE BATCH RECORD FOR LOT NUMBER 0001058342, BACT/ALERT® IAST AEROBIC CULTURE BOTTLES (PART 259786) WAS REVIEWED FOR ABNORMALITIES OR INDICATIONS OF EVENTS THAT MAY HAVE LED TO FALSE POSITIVES. THERE WERE NO UNUSUAL EVENTS ASSOCIATED WITH THIS LOT NUMBER, AND NO MANUFACTURING ERRORS WERE FOUND IN THE REVIEW. THE RECORDS DO NOT INDICATE THAT THE ROOT CAUSE IS RELATED TO THE BOTTLE MANUFACTURING. REVIEWS OF MANUFACTURING DATA FOR THE BACT/ALERT IAST BOTTLES DID NOT REVEAL ANY ADVERSE TREND RELATING TO POTENTIAL FALSE POSITIVE ISSUES. REVIEWS OF COMPLAINT DATA SHOWED NO ADVERSE TREND IS PRESENT FOR THE LOT 0001058342, NOR FOR THE ERROR CODE FALSE POSITIVE ACCELERATION - C326. ROOT CAUSE ANALYSIS AND CONCLUSION: THE BACKUP AND THE GRAPHS PROVIDED BY THE CUSTOMER WERE ANALYZED. THE FIVE WHY¿S ROOT CAUSE ANALYSIS TOOL WAS USED FOR THE INVESTIGATION PURPOSE. TWO MOST LIKELY ROOT CAUSES WERE IDENTIFIED BASED ON THE INFORMATION PROVIDED BY THE CUSTOMER AND THE DATA BACKUP ANALYSIS. 1- BOTTLES REFLECTANCE GRAPHS OF SIHKJVVV, SIHKNZGM AND SIHL4VM3 SHOWED ELONGATED TIME TO REACH SAMPLE EQUILIBRIUM. AS THE SAMPLE CONTAINS CELLS OR CELLULAR BY-PRODUCTS, IT MAY BE REACTING WITH THE SENSOR TO CAUSE THE INSTRUMENT FALSE POSITIVE RESULT. THE BOTTLE GRAPHS DO NOT HAVE A LARGE SIGMOIDAL SHAPED CURVE CONSISTENT WITH MICROBIAL GROWTH, AND THE SUBCULTURES OF THE BOTTLES WERE NO GROWTH INITIALLY FOR BOTTLES ID SIHKJVVV, SIHKNZGM AND SIHL4VM3 (NOT YET CONFIRMED FOR BOTTLE ID ST1569M6). CELLULAR ACTIVITY PRODUCES CO2 AND IS A KNOWN CAUSE OF INSTRUMENT FALSE POSITIVES. MOREOVER, A SLOW INCREASE IN STABILIZATION OF REFLECTANCE UNITS AFTER THE INITIAL LOAD HAS BEEN ASSOCIATED WITH ATMP SAMPLES, THEREFORE THE FALSE POSITIVE IS MOST LIKELY RELATED TO THE SAME TYPE. 2- LOADING RELATED FALSE POSITIVES SHOW SMALL SHIFTS IN GRAPH RELATED TO LOADING NEW BOTTLES IN THE SAME RACK/DRAWER WHEN THE FALSE POSITIVE BOTTLE WAS UNDER TEST. THESE SHIFTS ARE VERY VISIBLE IN ST1569M6 BOTTLE REFLECTANCE CURVE AND ARE LIKELY TO BE THE ROOT CAUSE TO THIS BOTTLE POSITIVE DETERMINATION. BOTTLE SIHKJVVV, SIHKNZGM AND SIHL4VM3 SHOWED THESE PATTERN AS WELL DUE TO UNLOADING EVENTS DURING THEIR INCUBATION, WHICH COULD HAVE CONTRIBUTED TO BOTTLES POSITIVE DETERMINATION. ADVICE AND RECOMMENDATIONS TO CUSTOMERS: THE INVESTIGATOR REVIEWED THE INSTRUCTIONS FOR USE [IFU] AND BACT/ALERT USER MANUAL FOR BACT/ALERT CULTURE BOTTLES WHICH PROVIDES GUIDANCE CONCERNING FALSE POSITIVE RESULTS: INDUSTRY CUSTOMERS ARE RESPONSIBLE FOR VALIDATING THE BACT/ALERT SYSTEM AND CULTURE BOTTLES FOR THEIR TESTING PURPOSES. USERS CONSIDERING THE BACT/ALERT SYSTEM AND CULTURE BOTTLES FOR RELEASE OF MEDICAL PRODUCTS, INCLUDING HUMAN BIOLOGICAL SUBSTANCES, SHOULD FIRST CONSULT THEIR APPROPRIATE REGULATORY AGENCY FOR REQUIREMENTS.¿ SHELF-LIFE OF CELL-BASED PREPARATIONS IS DEPENDENT ON THE CELL CHARACTERISTICS AND ON THE PRESERVATION CONDITIONS. FOR NON-CRYOPRESERVED CELL-BASED PREPARATIONS, THE SHELF-LIFE USUALLY DOES NOT EXCEED 3-4 DAYS AND SOMETIMES NOT MORE THAN A FEW HOURS. MEDIA AND INCUBATION TIMES USED IN METHODS FOR CELL-BASED PREPARATIONS MUST BE CHOSEN TO TAKE INTO ACCOUNT THE PROPERTIES OF THE SOURCE MATERIAL. A HIGH WHITE BLOOD CELL COUNT IN THE SAMPLE COMPOSITION CAN PRODUCE HIGH AMOUNTS OF CO2. BOTTLES CAN BE FLAGGED POSITIVE BY ACCELERATION OR RATE ALGORITHMS. LARGE BOTTLE LOADING AND UNLOADING EVENTS AT THE SAME TIME AND IN THE SAME AREAS, WILL CONTRIBUTE TO A VERY LARGE HEAT LOSS WITHIN THE RACKS. THIS MAY TRIGGER THE ACCELERATION OR RATE ALGORITHMS TO ERRONEOUSLY FLAG POSITIVE. POSITIVE BOTTLES SHOULD BE SUB-CULTURED AND SMEARED TO CONFIRM THE POSITIVE SIGNAL. THE SUBCULTURE AND GRAM STAINING SHOULD BE DONE AS SOON AS THE BOTTLE WAS DETERMINED POSITIVE, AND SHOULD NOT BE DONE AT THE END OF THE INCUBATION TIME.

    Description of Event or Problem · 0

    INTENDED USE: BACT/ALERT® I AST CULTURE BOTTLES ARE USED WITH THE BACT/ALERT® MICROBIAL DETECTION SYSTEMS IN QUALITATIVE PROCEDURES FOR ENHANCED RECOVERY AND DETECTION OF A VARIETY 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. ISSUE DESCRIPTION: A CUSTOMER IN THE UNITED STATES NOTIFIED BIOMÉRIEUX OF FALSE POSITIVE RESULTS IN ASSOCIATION WITH BACT/ALERT I AST CULTURE BOTTLE (REF. 259789), BATCH NUMBER UNKNOWN) WHILE TESTING CELL AND GENE THERAPY PRODUCTS. IT WAS REPORTED THAT THE CUSTOMER OBTAINED TWO FALSE POSITIVE RESULTS WITH A SAMPLE OF RE-ENGINEERED PATIENT CELL, A PHORESIS SAMPLE. ACCORDING TO THE AVAILABLE INFORMATION AT THE TIME OF ASSESSMENT, THE FIRST SAMPLE WAS POSITIVE AFTER 37 DAYS AND THE OTHER IS STILL NEGATIVE. THE CUSTOMER PERFORMED THE SUBCULTURE AT DAY 37 AND RESULTS WERE NEGATIVE FOR BOTH SAMPLES; NO ORGANISM WAS PRESENT IN THE PRODUCT. BIOMÉRIEUX GLOBAL CUSTOMER SERVICE (GCS) REQUESTED ADDITIONAL INFORMATION TO FURTHER INVESTIGATE THE CASE. AT THE TIME OF ASSESSMENT, THERE IS NO INDICATION OR REPORT FROM THE CUSTOMER THAT THE FALSE POSITIVE RESULTS LED TO ANY ADVERSE EVENT RELATED TO ANY PATIENT'S STATE OF HEALTH. THE IMPACTED PRODUCT REFERENCE (BACT/ALERT® I AST ¿ REF. 259786) IS NOT AN IVD PRODUCT; HOWEVER THE BACT/ALERT® SA (REF.259789 ) IS THE SAME FORMULATION AND IS AN IVD. BACT/ALERT® SA CULTURE BOTTLES ARE USED WITH BACT/ALERT® MICROBIAL DETECTION SYSTEMS IN QUALITATIVE PROCEDURES FOR THE RECOVERY AND DETECTION OF AEROBIC MICROORGANISMS (BACTERIA AND FUNGI) FROM BLOOD AND OTHER NORMALLY STERILE BODY FLUIDS. AN INVESTIGATION WILL BE INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2776426 BACT/ALERT I AST BACT/ALERT I AST MDB BIOMÉRIEUX, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown