BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BACT/ALERT FA PLUS (PLASTIC) 100 BTLS - 410851

    MDR report key: 20035366 · Received August 22, 2024

    Report

    Report Number
    3002769706-2024-00034
    Event Type
    Malfunction
    Date Received
    August 22, 2024
    Date of Event
    July 29, 2024
    Report Date
    October 29, 2024
    Manufacturer
    BIOMÉRIEUX, INC.
    Product Code
    MDB
    UDI-DI
    03573026357900
    PMA / PMN Number
    K121446
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENT REPORT HAS BEEN CREATED TO CLARIFY THE DATE OF AWARENESS BY BIOMÉRIEUX, INC. RELATED TO THE ASSOCIATION OF THE BACT/ALERT® FA PLUS CULTURE BOTTLE (REF. (B)(4) TO THE CORRESPONDING REPORTABLE EVENT FOR BIOFIRE BCID2 PANEL (REF. (B)(4). BIOMÉRIEUX BACT/ALERT BECAME AWARE OF THE EVENT ON 08-AUG-2024, WITH A REPORTING DUE DATE OF 07-SEP-2024.

    Additional Manufacturer Narrative · 0

    CONTEXT/PROBLEM DESCRIPTION: SEVERAL CUSTOMERS NOTIFIED BIOMÉRIEUX OF INOCULATED BACT/ALERT® FA PLUS (PART 410851) LOT 0004102408 BLOOD CULTURE BOTTLES HAVING NUCLEIC ACID INTERFERENCE WITH BIOFIRE BCID2 MOLECULAR TESTING PANEL. THE BCID2 TEST RESULTS FOR THE PATIENT BOTTLES SHOWED THE DETECTION OF SERRATIA MARCESCENS; HOWEVER, THE SUBCULTURES FROM THE POSITIVE BOTTLES DID NOT CONFIRM THE PRESENCE OF THIS ORGANISM. THERE WAS NO EVIDENCE THAT THE BACT/ALERT SYSTEM DID NOT PERFORM AS INTENDED TO DETECT MICROBIAL GROWTH IN THE BLOOD CULTURE TEST. THE COMPLAINT WAS ASSOCIATED WITH CLINICAL FALSE POSITIVE RESULTS WHEN CONTENTS OF POSITIVE FA PLUS BOTTLES WERE FURTHER TESTED WITH BLOOD CULTURE IDENTIFICATION (BCID) SYSTEMS, USING POLYMERASE CHAIN REACTION (COPIES OF ORGANISM DNA FOR IDENTIFICATION). THERE WAS NO INDICATION THAT THIS EVENT LED TO ANY ADVERSE DETECTION TO ANY PATIENTS¿ HEALTH. THE PRESENCE OF NUCLEIC ACIDS FROM NON-VIABLE MICROORGANISMS, ALONE, WILL NOT CAUSE THE BACT/ALERT BOTTLE TO FLAG AS POSITIVE FOR GROWTH AS THE ORGANISM IS NOT VIABLE AND CANNOT GROW IN THE BOTTLE. THE INSTRUCTIONS FOR USE FOR THE BIOFIRE BCID2 PROVIDE ADEQUATE DIRECTIONS FOR DETECTION OF NON-VIABLE ORGANISMS OR NUCLEIC ACID LEVELS. THESE PRODUCTS ARE TO BE USED IN CONJUNCTION WITH OTHER DIAGNOSTIC TEST RESULTS FOR THE TREATMENT OF PATIENTS. IMPACT: POTENTIAL RISK FOR INTERFERENCE WITH CUSTOMER USE OF THE BACT/ALERT CULTURE BOTTLES FOR CONTINUOUS MICROBIAL MONITORING IN CONJUNCTION WITH BCID TESTS IMPACTS CLINICAL WORKFLOW OF THE LABORATORY AND COULD HAVE AN IMPACT ON PATIENT TREATMENT. THE POTENTIAL IMPACT TO PATIENTS WAS THAT THEY COULD HAVE BEEN TREATED WITH ONE OR MORE BROAD SPECTRUM ANTIBIOTICS RATHER THAN A MORE TARGETED ANTIBIOTIC THERAPY WITH POSSIBLE RISKS ASSOCIATED WITH MEDICATION. NUCLEIC ACID INTERFERENCE WITH DOWNSTREAM MOLECULAR PROCESSING/TESTING PERTAINS TO THIS COMPLAINT ISSUE. THE FUNCTIONALITY OF THE BACT/ALERT REAGENT BOTTLE ITSELF IS NOT IMPACTED. ALTHOUGH BACT/ALERT FA PLUS BOTTLES PERFORMED ACCORDING TO THE INTENDED USE AND WITHIN THE EXPECTED SPECIFICATIONS, IT WAS DECIDED BY A CROSS FUNCTIONAL TEAM CONSISTING OF DURHAM (BACT/ALERT PRODUCT) AND SALT LAKE CITY (BIOFIRE BCID2 PANEL PRODUCT) REPRESENTATIVES TO ADD LOT 0004102408 TO A JOINT FIELD SAFETY CORRECTIVE ACTION (FSCA) COMMUNICATION TO CUSTOMERS THAT USE THESE TWO PRODUCTS TOGETHER. THE FSCA PERTAINS TO CUSTOMERS¿ FALSE POSITIVE COMPLAINTS FOR S. MARCESCENS WHEN USING BIOFIRE BCID2 WITH SPECIFIC LOTS OF BACT/ALERT CULTURE BOTTLES. THE FSCA WAS INITIATED AND IMPLEMENTED BY THE SALT LAKE CITY SITE. ROOT CAUSE ANALYSIS: ROOT CAUSE ANALYSIS FOR THE FALSE POSITIVE DETECTION OF SERRATIA MARCESCENS WAS CONDUCTED BY USING THE ¿5M+1E¿ METHOD OF ANALYSIS TO IDENTIFY THE ROOT CAUSE/CONTRIBUTING ROOT CAUSES FOR THIS ISSUE. THE ROOT CAUSE ASSESSMENT CONCLUDED THE FOLLOWING CATEGORY ATTRIBUTED TO THIS ISSUE: ¿ METHOD/PROCESS: STUDIES PERFORMED DURING THIS INVESTIGATION INDICATE THAT NUCLEIC ACIDS OF ENTEROBACTERALES CAN BE PRESENT IN THE MEDIA FLOW DURING PRODUCTION, MOST EVIDENT DURING THE END OF FILLING. BCID2 DETECTIONS DO NOT ALWAYS CORRELATE WITH BIOBURDEN TEST RESULTS (NUMBER OF VIABLE ORGANISMS PRIOR TO THE AUTOCLAVE PROCESS FOR BOTTLES). BACT/ALERT PROCESSES WERE NOT DESIGNED TO BE FREE OF NUCLEIC ACIDS OF ORGANISMS (E.G., NON-VIABLE DNA ASSOCIATED WITH ENTEROBACTERALES) THE EXACT SOURCE OF NON-VIABLE NUCLEIC ACIDS FOR ENTEROBACTERALES (E.G., SERRATIA MARCESCENS) IS DIFFICULT TO DETERMINE DUE TO THE LIMITATIONS WITH SAMPLING THE MEDIA FLOW PATHWAY AND ACQUIRING A LARGER NUMBER OF BOTTLES (SAMPLING) THAT CAN REASONABLY BE TESTED WITH THE BCID2 PANEL. THE FOLLOWING ACTIONS HAVE BEEN IMPLEMENTED: REVISED SAMPLING OF BOTTLES FROM ALL MEDIA BULKS OF A FILL LOT CUSTOMER LETTER FOR POTENTIAL FALSE POSITIVE DETECTIONS OF ENTEROBACTERALES (E.G., SERRATIA MARCESCENS) WHEN USING BCID2 PANEL WITH SPECIFIC BACT/ALERT BOTTLES (E.G., 0004102408). THIS BOTTLE LOT WAS ADDED TO FIELD ACTION #000022. CONTINUOUS IMPROVEMENT MONITORING: PARALLEL MEDIA LINES: ADD A SECOND TRANSFER LINE FROM MEDIA FORMULATION TO FILLING AND THIS WILL REDUCE CLEANING CYCLE TIMES BETWEEN PRODUCTION RUNS. WHILE ONE TRANSFER LINE MOVES MEDIA THROUGH THE FILLING PROCESS, THE SECOND TRANSFER LINE WILL BE RUNNING A CLEANING CYCLE. NO CHANGE TO BACT/ALERT BOTTLE DESIGN OR FUNCTION. REDUCING THE NUMBER OF MEDIA BULKS FOR EACH FILLING LOT WILL POTENTIALLY REDUCE BCID2 DETECTION ISSUES. QUANTITATIVE APPROACH INSTEAD OF THE CURRENT QUALITATIVE APPROACH TO BCID2 TESTING WITH BACT/ALERT BOTTLES IN QC RELEASE TESTING ACTION ITEMS SUPPORTING FILL LINE OPERATION AND ANY REVISED SAMPLING FOR BCID2 PANEL TESTING WITH BACT/ALERT BOTTLES ASSOCIATED WILL BE INTERNALLY TRACKED BY APPROPRIATE PERSONNEL. RETAINS: FINISHED PRODUCT SAMPLES FROM FA PLUS LOT 0004102408 WERE NOT REQUIRED FOR DETERMINING ROOT CAUSE FOR THIS INVESTIGATION DUE TO THE EXTENSIVE EVALUATION OF THIS LOT BY THE DURHAM MANUFACTURING SITE. RETURNED PRODUCTS AND TESTING: THREE (3) CUSTOMERS SENT AND/OR TESTED UNINOCULATED BOTTLES FROM FA PLUS LOT 0004102408. THE RESULTS ARE SUMMARIZED BELOW: CUSTOMER 1: FIVE (5) UNINOCULATED BACT/ALERT BOTTLES FROM FA PLUS LOT 0004102408 (EXPIRY DATE 16FEB2025) WERE SENT TO BIOFIRE. BOTTLES WERE TESTED WITH BCID2 PANEL AND ALL HAD DETECTION FOR SERRATIA MARCESCENS. BOTTLE SAMPLES WERE CULTURED, AND NO GROWTH WAS OBSERVED, CONFIRMING MEDIA CONTAMINATION WITH NON-VIABLE NUCLEIC ACIDS. THIS CUSTOMER ALSO TESTED AN UNINOCULATED FA PLUS BOTTLE FROM LOT 0004102408 WITH A BCID2 PANEL AND THE RESULT WAS DETECTION OF SERRATIA MARCESCENS, BOTTLE CONTAMINATION. CUSTOMER MOVED THIS LOT OF BOTTLES TO A LOCATION THAT DOES NOT PERFORM BCID2 TESTING. CUSTOMER 2: THE CUSTOMER PERFORMED ADDITIONAL TESTING USING UNINOCULATED BACT/ALERT BOTTLES FROM FA PLUS LOT 0004102408. BOTTLES WERE INCUBATED FOR 5 DAYS AND TESTED WITH THE BCID2 PANEL. THE RESULT WAS DETECTION OF SERRATIA MARCESCENS AND ENTEROBACTERALES. ANOTHER RUN WAS PERFORMED WITH AN UNINOCULATED BOTTLE AND BCID2 PANEL WHICH SHOWED A WEAK RESULT FOR SERRATIA MARCESCENS. CUSTOMER 3: THE CUSTOMER PERFORMED TWO (2) UNINOCULATED BOTTLES AND ONE (1) WAS FROM FA PLUS LOT 0004102408. DETECTION OF ENTEROBACTERALES AND SERRATIA MARCESCENS INDICATED MOST LIKELY CAUSE WAS DUE TO NON-VIABLE ORGANISM OR NUCLEIC ACID COMPONENTS. DEVICE HISTORY RECORD AND COMPLAINT TRENDS: DEVICE HISTORY RECORD REVIEWS WERE CONDUCTED FOR THE FA PLUS LOT. QUERIES FOR MANUFACTURING DEVIATIONS AND COMPLAINT RECORDS SHOWED NO ADVERSE TREND FOR NUCLEIC ACID INTERFERENCE. CONCLUDE PRODUCT COMPLIANCE TO SPECIFICATION/PERFORMANCE: THERE IS NO EVIDENCE OF ANY BOTTLE MALFUNCTION WITH THE BACT/ALERT FA PLUS CULTURE BOTTLE LOT. THE BACT/ALERT BOTTLES DETECTED ORGANISM GROWTH AS INTENDED. BCID2 TESTING IS BEING CONDUCTED ON DESIGNATED RAW MATERIALS AND SAMPLES REPRESENTING ALL MEDIA BULKS FOR THE FILL LOTS FOR BACT/ALERT PRODUCTS. TESTING OF ALL THE MEDIA BULKS THAT CONTRIBUTE TO THE FILL LOT FILLS WILL AID IN MONITORING PRODUCT CONTAINING NUCLEIC ACID RESIDUAL IN AN EFFORT TO REDUCE THE CHANCES OF CUSTOMERS OBTAINING FALSE POSITIVE RESULTS WITH BCID2 PANEL TESTING. ADVICE AND RECOMMENDATIONS FOR CUSTOMER: THE INVESTIGATOR REVIEWED THE INSTRUCTIONS FOR USE [IFU] FOR BACT/ALERT BOTTLES AND BCID2 PANEL. IMPORTANT POINTS TO CONSIDER ARE SUMMARIZED BELOW: ALL POSITIVE BACT/ALERT BOTTLES SHOULD BE ACCOMPANIED BY GRAM STAIN AND SUBCULTURE RESULTS AS PER IFU. THE BIOFIRE BCID2 PANEL IFU STATES ¿ANY BLOOD CULTURE MEDIA MAY CONTAIN NON-VIABLE ORGANISMS AND/OR NUCLEIC ACID AT LEVELS THAT CAN BE DETECTED BY THE BIOFIRE BCID2 PANEL LEADING TO FALSE POSITIVE TEST RESULTS.¿ THE PRESENCE OF NON-VIABLE ORGANISMS DOES NOT COMPROMISE THE INTENDED FUNCTION OF THE BLOOD CULTURE BOTTLES. BCID2 PANELS ARE POLYMERASE CHAIN REACTION (PCR) TESTS WHICH CANNOT DETECT THE DIFFERENCE BETWEEN VIABLE AND NON-VIABLE ORGANISMS. BCID2 PANEL RESULTS SHOULD BE CONFIRMED (E.G., SUBCULTURE) BEFORE REPORTING, UNLESS THE RESULT IS IN AGREEMENT WITH OTHER LABORATORY, EPIDEMIOLOGICAL, OR CLINICAL FINDINGS AS PER THE IFU.

    Description of Event or Problem · 0

    INTENDED USE: BACT/ALERT® FA PLUS CULTURE BOTTLES ARE USED WITH BACT/ALERT® MICROBIAL DETECTION SYSTEMS IN QUALITATIVE PROCEDURES FOR RECOVERY AND DETECTION OF AEROBIC AND FACULTATIVE ANAEROBIC (BACTERIA AND YEAST) FROM BLOOD AND OTHER NORMALLY STERILE BODY FLUIDS. ISSUE DESCRIPTION: A NOTIFICATION WAS RECEIVED FROM BIOFIRE THAT THEY HAD RECEIVED A CUSTOMER COMPLAINT (FROM CHILE) OF BCID FALSE POSITIVE RESULTS FOR SERRATIA MARCESCENS ASSOCIATED WITH BACT/ALERT FA PLUS (PLASTIC) 100 BTLS - REF. 410851, LOT 0004102408, EXPIRY 16-FEB-2025). RESULTS FOR SIX (6) PATIENTS WERE IMPACTED. SUMMARY: BCID: SERRATIA MARCESCENS. SUBCULTURE REPORTS: PSEUDOMONAS AERUGINOSA, ENTEROBACTERALES. NO EVIDENCE OF SERRATIA MARCESCENS WAS IDENTIFIED. THE BACT/ALERT BOTTLE IS A QUALITATIVE TEST, DETECTING THE PRESENCE OR ABSENCE OF AN ORGANISM; THE BOTTLE FUNCTIONED AS INTENDED IN SIGNALING POSITIVE FOR THE ORGANISM THAT WAS IN FACT PRESENT (PSEUDOMONAS OR ENTERBACERALES, IN THESE CASES). THERE IS A POSSIBILITY OF THE PRESENCE OF NUCLEIC ACIDS FROM NON-VIABLE MICROORGANISMS IN THE MEDIA USED IN THE BACT/ALERT BOTTLES. THE PRESENCE OF NUCLEIC ACIDS FROM NON-VIABLE MICROORGANISMS, ALONE, WILL NOT CAUSE THE BACT/ALERT BOTTLE TO FLAG AS POSITIVE FOR GROWTH AS THE ORGANISM IS NOT VIABLE AND CANNOT GROW IN THE BOTTLE. THE PHYSICIAN SHOULD USE ALL INFORMATION AVAILABLE ON THE PATIENT TO INTERPRET THE BIOFIRE® FILMARRAY® BCID2 PANEL RESULTS ACCORDINGLY. THE PRESENCE OF CONTAMINATING NUCLEIC ACID FROM NON-VIABLE MICROORGANISMS IN THE MEDIA, NOT FROM THE PATIENT SAMPLE, IS A POSSIBILITY THAT MUST BE CONSIDERED WHEN INTERPRETING THE BIOFIRE® FILMARRAY® BCID2 PANEL RESULTS. THERE IS NO INDICATION OR REPORT FROM THE LABORATORY THAT THE REPORTED BCID ISSUE LED TO ANY ADVERSE EVENT RELATED TO ANY PATIENT'S STATE OF HEALTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    941172 BACT/ALERT FA PLUS (PLASTIC) 100 BTLS - 410851 BACT/ALERT FA PLUS (PLASTIC) 100 BTLS - 410851 MDB BIOMÉRIEUX, INC. 0004102408 03573026357900

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown