BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BACT/ALERT® I NST

    MDR report key: 14162328 · Received April 20, 2022

    Report

    Report Number
    3002769706-2022-00026
    Event Type
    Malfunction
    Date Received
    April 20, 2022
    Report Date
    January 6, 2023
    Manufacturer
    BIOMÉRIEUX, INC.
    Product Code
    MDB
    PMA / PMN Number
    K021123
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION WAS INITIATED IN RESPONSE TO A CUSTOMER COMPLAINT OF OBTAINING AN INSTRUMENT FALSE POSITIVE RESULT WHILE TESTING AN ATMP (ADVANCED THERAPEUTIC MEDICAL PRODUCT) SAMPLE WITH THE BACT/ALERT® I NST (REF 259785, LOT 0001057230) WITH THE BTA3D COMBINATION MODULE LEFT - 200291. COMPLAINT TREND ANALYSIS: AN ERROR CODE QUERY WAS PERFORMED FOR THE DATE RANGE OF APPROXIMATELY 13 MONTHS PRIOR TO COMPLAINT CONTACT DATE TO DATE OF QUERY GENERATION, 22MAR2021 TO 02DEC2022. CATALOG PROFILE B19, BACT/ALERT INST BOTTLE PART NUMBER 259785, AND THE ERROR CODE FALSE POSITIVE ACCELERATION - C326 WERE CHOSEN AS THEY RELATE TO THIS COMPLAINT INVESTIGATION. THE DATA WAS FURTHER FILTERED FOR THE INDUSTRY HEALTHCARE MARKET. THE ERROR CODE QUERY IDENTIFIED EIGHT (8) COMPLAINT CASES, INCLUDING THE COMPLAINT (B)(4) UNDER THIS INVESTIGATION. SIX (6) OF THESE OTHER CASES WERE FROM ONE CUSTOMER AND THE INVESTIGATION PERFORMED FOUND THE MOST LIKELY ROOT CAUSE WAS EXCESSIVE DRAWER OPENINGS CAUSING NOISE IN A FEW BOTTLE GRAPHS THAT LED TO AN INSTRUMENT FALSE POSITIVE. ONE (1) CASE IS THOUGHT TO BE SAMPLE RELATED. A SECOND QUERY FOR THE BOTTLE LOT NUMBER 0001057230 WAS PERFORMED. TWO COMPLAINTS WERE RETURNED ON THIS QUERY, ONE IS THE COMPLAINT (B)(4) UNDER THIS INVESTIGATION. THE SECOND COMPLAINT IS NOT RELATED TO THIS INVESTIGATION BECAUSE IT IS FOR A DIFFERENT ERROR CODE NOT RELATED TO ANY FALSE POSITIVE RESULT AND IS FROM A DIFFERENT CUSTOMER. THE INVESTIGATOR CONCLUDES THERE IS NO ADVERSE TREND IN THE COMPLAINT DATA FOR THIS COMPLAINT INVESTIGATION. INSTRUCTIONS FOR USE (IFU) REVIEW: THE INVESTIGATOR REVIEWED THE BACT/ALERT INST PART 259785 CULTURE BOTTLE IFU (DOCUMENT (B)(4)): INTENDED USE: BACT/ALERT® I NST CULTURE BOTTLES ARE USED WITH THE BACT/ALERT® MICROBIAL DETECTION SYSTEMS IN QUALITATIVE PROCEDURES FOR ENHANCED RECOVERY AND DETECTION OF A VARIETY OF ANAEROBIC AND FACULTATIVE MICROORGANISMS. THE LABORATORY IS RESPONSIBLE FOR VALIDATING THE BACT/ALERT® SYSTEM AND CULTURE BOTTLES FOR THEIR TESTING PURPOSES. THE INVESTIGATOR FOUND THE IFU IS ADEQUATE, AND NO UPDATE IS NEEDED. THE BACT/ALERT 3D USER MANUAL (DOCUMENT (B)(4)): PAGE 6.31 FOR LOADING BOTTLES STATES CAUTION: IF A LARGE NUMBER OF BOTTLES ARE LOADED INTO THE INCUBATION MODULE AT THE SAME TIME AND IN THE SAME AREAS, A LARGE HEAT MASS LOSS WITHIN THE RACKS MAY OCCUR. THIS HEAT LOSS MAY TRIGGER THE ACCELERATION OR RATE ALGORITHMS TO ERRONEOUSLY FLAG POSITIVE. APPENDIX C BEST PRACTICES DISCUSSES HOW TO AVOID INSTRUMENT FALSE POSITIVES. MANUFACTURING DIRECTIONS (MD) REVIEW: THE INVESTIGATOR DID NOT PERFORM A MANUFACTURING BATCH RECORD REVIEW BECAUSE EVALUATION OF THE BOTTLE GRAPH AND INSTRUMENT BACKUP DID NOT INDICATE THERE WAS A REAGENT MALFUNCTION. THE MOST LIKELY ROOT CAUSE WAS RELATED TO THE CUSTOMERS LOADING PATTERN FOR NEW BOTTLES. CUSTOMER DATA REVIEW: THE INVESTIGATION REVIEWED THE INFORMATION PROVIDED BY THE CUSTOMER, THE BOTTLE GRAPHS, AND AN ANALYSIS OF THE BACT/ALERT 3D INSTRUMENT BACKUP. THERE IS NO EVIDENCE OF A REAGENT BOTTLE MALFUNCTION. ROOT CAUSE: THE INVESTIGATOR USED THE FIVE WHY¿S ROOT CAUSE ANALYSIS TOOL TO EVALUATE THE COMPLAINT. THE MOST LIKELY ROOT CAUSE WAS FOUND TO BE RELATED TO THE USER¿S LOADING PATTERN FOR NEW BOTTLES PER THE BACKUP ANALYSIS. THE INVESTIGATOR EXAMINED THE BACT/ALERT 3D B.50 BACKUP MADE ON 25MAR2022. THERE WERE 10 BOTTLES LOADED AND 1 UNLOADED FROM DRAWER 1A IN THE 8 HOURS BEFORE THE POSITIVE FLAG FOR ST145H44 IN CELL 1A60. THE BOTTLE READINGS WERE EXTRACTED AND SHOW A SMALL ACCELERATION (HUMP) IN THE GRAPH WHEN ZOOMED IN, THAT MIGHT BE RELATED TO THE TEMPERATURE CHANGE IN THE RACK WHEN THESE NEW BOTTLES WERE LOADED WHILE THIS BOTTLE WAS UNDER TEST. NO INSTRUMENT FAULTS ARE SEEN THAT WOULD CONTRIBUTE TO THIS POSITIVE FLAG. THERE IS NO EVIDENCE OF A REAGENT BOTTLE MALFUNCTION. THE MOST LIKELY ROOT CAUSE WAS FOUND TO BE RELATED TO THE USER¿S LOADING PATTERN FOR NEW BOTTLES PER THE BACKUP ANALYSIS. LOCAL CUSTOMER SERVICE (LCS) HAS BEEN REQUESTED TO ASK THE CUSTOMER TO ONLY LOAD ONE NEW BOTTLE IN A RACK WHERE BOTTLES ARE ALREADY TESTING TO MINIMIZE THE TEMPERATURE CHANGE IN THE RACK. SPREAD NEW BOTTLE LOADS THROUGH ALL AVAILABLE RACKS ON THE SYSTEM. IF A RACK IS EMPTY, THEN MULTIPLE BOTTLES MAY BE LOADED AT ONE TIME. AVOID CAUSING ERROR 20 ALARM ¿ DRAWER OPEN LONGER THAN 2 MINUTES.

    Description of Event or Problem · 0

    INTENDED USE: BACT/ALERT® I NST CULTURE BOTTLES ARE USED WITH THE BACT/ALERT® MICROBIAL DETECTION SYSTEMS IN QUALITATIVE PROCEDURES FOR ENHANCED RECOVERY AND DETECTION OF A VARIETY OF ANAEROBIC AND FACULTATIVE MICROORGANISMS. THE LABORATORY IS RESPONSIBLE FOR VALIDATING THE BACT/ALERT® SYSTEM AND CULTURE BOTTLES FOR THEIR TESTING PURPOSES. DESCRIPTION: A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF OBTAINING AN INSTRUMENT FALSE POSITIVE RESULT WHILE TESTING AN ATMP (ADVANCED THERAPEUTIC MEDICAL PRODUCT) SAMPLE WITH THE BACT/ALERT® I NST (REF 259785, LOT 0001057230) WITH THE BTA3D COMBINATION MODULE LEFT - 200291. THE MATERIAL WAS A 2ML SAMPLE OF CELL CULTURE SUPERNATANT FROM A PRODUCT INTENDED FOR CANCER TREATMENT. THE SAMPLE WAS COLLECTED FROM THE FINAL PRODUCT. THE CUSTOMER REPORTED THAT THE BOTTLE FLAGGED AS POSITIVE, BUT WHEN A GRAM STAIN AND SUBCULTURE WERE PERFORMED, THERE WERE NO MICROORGANISMS PRESENT (NEGATIVE). THE BOTTLE REPORTEDLY LOOKED NORMAL AND THE SENSOR WAS GRAY (INDICATING NO GROWTH). THERE WERE NO ISSUES REPORTED. THE BOTTLE LOADING WAS NOT DELAYED. THERE IS NO INDICATION OR REPORT FROM THE CUSTOMER THAT THIS EVENT LED TO ANY ADVERSE EVENT RELATED TO ANY PATIENT'S STATE OF HEALTH. THE IMPACTED PRODUCT REFERENCE (BACT/ALERT® I NST ¿ REF. (B)(4)) IS NOT AN IVD PRODUCT, HOWEVER THE BACT/ALERT® SN ¿ REF. (B)(4) IS THE SAME FORMULATION AND IS AN IVD. AN INVESTIGATION HAS BEEN INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1409718 BACT/ALERT® I NST BACT/ALERT® I NST MDB BIOMÉRIEUX, INC. 0001057230

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown