BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BACT/ALERT BPA EU - 279044

    MDR report key: 18067244 · Received November 3, 2023

    Report

    Report Number
    3002769706-2023-00023
    Event Type
    Malfunction
    Date Received
    November 3, 2023
    Report Date
    February 13, 2024
    Manufacturer
    BIOMÉRIEUX INC.
    Product Code
    MZC
    PMA / PMN Number
    BK200472
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    COMPLAINT INVESTIGATION (B)(4) WAS INITIATED IN RESPONSE TO ONE CUSTOMER COMPLAINT RELATING TO FALSE POSITIVE RESULTS WITH BACT/ALERT® BPA EU (PART 279044, LOT 0001059651 EXPIRY 14DEC2023), TESTING OCCURRING ON BACT/ALERT® VIRTUO® INSTRUMENT WITH PLATELET SAMPLES. THE COMPLAINT IS FROM AN INDUSTRY BLOOD BANK CUSTOMER (CROATIAN INSTITUTE FOR TRANSFUSION MEDICINE, CONTACT DATE 25OCT2023), REPORTED THROUGH DISTRIBUTOR A&B D.O.O, LOCATED IN CROATIA. THE CUSTOMER IS TESTING PLATELET SAMPLES, USING BACT/ALERT® VIRTUO® (SOFTWARE 3.01.01.1274) WITH SERIAL NUMBERS (B)(6). AT THE TIME OF THE CASE OPENING, THE CUSTOMER WAS REPORTING TWO FALSE POSITIVE RESULTS. DURING CASE TROUBLESHOOTING AND INVESTIGATION, THREE ADDITIONAL BOTTLES WERE REPORTED TO HAVE BEEN FLAGGED AS POSITIVE WHEN SUBCULTURE WAS NEGATIVE. DISTRIBUTOR PROVIDED THE BOTTLES IDS ASSOCIATED WITH THE FALSE POSITIVE RESULTS: PAV4T456, PAV4T9LT, PAV4T8NM, PAV4T7W6 AND PAV4T7SL, ALL ARE BACT/ALERT® BPA EU CULTURE BOTTLES (PART 279044) FROM LOT 0001059651, WITH EXPIRY DATE 14DEC2023. THE DISTRIBUTOR PROVIDED THE LOG FILES FROM THE VIRTUO SYSTEM FOR INVESTIGATION PURPOSES. THE SCOPE OF THE INVESTIGATION IS FOR ONE BLOOD BANK CUSTOMER SITE THAT RECEIVED A TOTAL OF FIVE FALSE POSITIVE RESULTS WITH BACT/ALERT® BPA EU LOT 0001059651. IMPACT: IT WAS REPORTED THAT A CUSTOMER IDENTIFIED FIVE FALSE POSITIVE RESULTS WITH FIVE BACT/ALERT® BPA EU CULTURE BOTTLES WHEN TESTING PLATELET SAMPLES. NO IMPACT/HARM TO PATIENTS/RECIPIENTS WAS REPORTED BY THE CUSTOMER. THE IMPACT TO CUSTOMER IS HAVING TO PERFORM ADDITIONAL TESTING TO CONFIRM A FALSE POSITIVE RESULT WHICH IS INDICATED BY A POSITIVE RESULT BY THE INSTRUMENT AND A NO GROWTH OF ANY ORGANISM IN THE CULTURE BOTTLE. THE IMPACT TO THE BUSINESS IS THAT THE CUSTOMER¿S UNCERTAINTY OF AN INSTRUMENT POSITIVE RESULT WITH THE SAMPLE OF PRODUCT AND WILL CAUSE CUSTOMERS TO LOSE CONFIDENCE IN THE SYSTEM. THE RISK DOCUMENTS ASSOCIATED BACT/ALERT BPA/BPN BLOOD CULTURE PRODUCT WAS REVIEWED, CLINICAL FALSE POSITIVE DUE TO SAMPLE COMPOSITION (LEUKOCYTES) WAS IDENTIFIED AS CLOSER TO THE MOST LIKELY ROOT CAUSE TO CUSTOMER¿S FALSE POSITIVE RESULTS. THIS RISK IS ASSOCIATED WITH SAMPLE COMPOSITION (E.G. IMPROPERLY LEUKOCYTE REDUCED). THE RATE OF THIS OCCURRENCE IS LOW; THEREFORE, THE FINAL RISK IS LOW FOR THIS ISSUE OF SAMPLE COMPOSITION. IMMEDIATE ACTION DONE BY LCS AND/OR WORKAROUND E.G. FSE/WORK ORDER (IF APPLICABLE): THE CUSTOMER CONFIRMED THE RESULTS BY SUBCULTURING THE FIVE BACT/ALERT® BPA CULTURE BOTTLES FLAGGED AS POSITIVE BY CUSTOMER¿S VIRTUO INSTRUMENTS. THE DISTRIBUTOR PROVIDED EACH BACKUP FILE OF BACT/ALERT® VIRTUO INSTRUMENT TO GICS FOR EVALUATION. INVESTIGATION: ROOT CAUSE ANALYSIS AND CONCLUSION: THE ROOT CAUSE ASSESSMENT SHOWED THAT THE MANUFACTURING PROCESSES ARE CAPTURED IN PROCEDURAL DIRECTIONS ON A ROUTINE BASIS AND RESULTS OF THESE DIRECTIONS ARE DOCUMENTED AS PART OF GOOD MANUFACTURING PRACTICES. MONITORING AND DETECTION METHODS RELATING TO POTENTIAL FALSE POSITIVE RESULTS ARE APPROPRIATELY IN PLACE AT THE DURHAM MANUFACTURING SITE. THE PACKAGING AQL INSPECTION RECORD AND THE FINAL AQL VISUAL INSPECTION SUMMARY AND DISPOSITION RECORD ARE IN PLACE TO IDENTIFY BOTTLE DEFECTS RELATING TO POTENTIAL FALSE POSITIVE RESULTS ASSOCIATED WITH MANUFACTURING PROCESSES OF BACT/ALERT® CULTURE BOTTLES. THE IFU FOR THE BACT/ALERT® BPA ALONG WITH THE BACT/ALERT® VIRTUO USER MANUAL PROVIDE ADEQUATE GUIDANCE ON HOW TO REDUCE THE CHANCES OF A USER OBTAINING FALSE POSITIVE RESULTS. MANUFACTURING EQUIPMENT IS MAINTAINED FOR OPERATION AND PROCEDURES ARE IN PLACE TO ADDRESS CALIBRATION AND RECOVERY DUE TO MALFUNCTIONS. ENVIRONMENTAL MONITORING OCCURS ON A ROUTINE BASIS IN THE MANUFACTURING FACILITY FOR BACT/ALERT® CULTURE BOTTLES. THE BACT/ALERT VIRTUO BACKUP DATA WERE REVIEWED BY GICS. THE BOTTLE DETAILS WERE CHECKED FOR THE FIVE BOTTLES IDENTIFIED AS FALSE POSITIVE (PAV4T7W6, PAV4T7SL, PAV4T9LT, PAV4T456, PAV4T8NM): - BOTTLE PAV4T7W6 WAS LOADED INTO THE VIRTUO ((B)(6)) INTO CELL 1-L21 ON (B)(6) 2023 AT 10:18 LOCAL TIME. THE BOTTLE WAS DETERMINED POSITIVE BY THE AREA ALGORITHM ON (B)(6)2023 AT 16:46 LOCAL TIME FOR A TOTAL INCUBATION TIME OF 6,5HOURS. THE BOTTLE WAS UNLOADED ON (B)(6) 2023 AT 15:52 LOCAL TIME. - BOTTLE PAV4T7SL WAS LOADED INTO THE VIRTUO ((B)(6)) INTO CELL 1-K23 ON (B)(6) 2023 AT 10:17 LOCAL TIME. THE BOTTLE WAS DETERMINED POSITIVE BY THE AREA ALGORITHM ON (B)(6) 2023 AT 19:07 LOCAL TIME FOR A TOTAL INCUBATION TIME OF 8,8HOURS. THE BOTTLE WAS UNLOADED ON (B)(6) 2023 AT 7:16 LOCAL TIME. - BOTTLE PAV4T9LT WAS LOADED INTO THE VIRTUO ((B)(6)) INTO CELL 1-I23 ON (B)(6) 2023 AT 07:49 LOCAL TIME. THE BOTTLE WAS DETERMINED POSITIVE BY THE AREA ALGORITHM ON (B)(6) 2023 AT 14:37 LOCAL TIME FOR A TOTAL INCUBATION TIME OF 6.8 HOURS. THE BOTTLE WAS UNLOADED ON (B)(6) 2023 AT 14:38 LOCAL TIME. - BOTTLE PAV4T456 WAS LOADED INTO THE VIRTUO ((B)(6)) INTO CELL 1-I19 ON (B)(6) 2023 AT 07:51 LOCAL TIME. THE BOTTLE WAS DETERMINED POSITIVE BY THE AREA ALGORITHM ON (B)(6) 2023 AT 16:07 LOCAL TIME FOR A TOTAL INCUBATION TIME OF 8,3 HOURS. THE BOTTLE WAS UNLOADED ON (B)(6) 2023 AT 16:19 LOCAL TIME. - BOTTLE PAV4T8NM WAS LOADED INTO THE VIRTUO ((B)(6)) INTO CELL 1-J9 ON (B)(6) 2023 AT 09:50 LOCAL TIME. THE BOTTLE WAS DETERMINED POSITIVE BY THE AREA ALGORITHM ON (B)(6) 2023 AT 17:32 LOCAL TIME FOR A TOTAL INCUBATION TIME OF 7,7 HOURS. THE BOTTLE WAS UNLOADED ON (B)(6) 2023 AT 06:50 LOCAL TIME. THE BACKUP DATA COLLECTED FROM THE CUSTOMER¿S SYSTEM WAS EXAMINED FOR FACTORS THAT MAY HAVE CONTRIBUTED TO THE FALSE POSITIVE RESULTS FOR THE BOTTLES LISTED. READINGS OF BOTTLES WERE EXTRACTED AND SENT TO BIOMATH (INTERNAL VIRTUO EXPERT UNIT) FOR EVALUATION. THE BIOMATH DEPARTMENT INDICATED THAT BOTTLES REFLECTANCE CURVES ARE CURVING SLIGHTLY UPWARD WHICH RESULTED IN SLOW INCREASING SLOPE. BASED ON THIS REVIEW, BIOMATH CONCLUDED THAT THERE WAS NO MISBEHAVIOR OF VIRTUO ALGORITHM FOR ANALYSIS OF THE BOTTLES. THE BLOOD CULTURE SUPPORT TEAM ALSO REVIEWED THE INSTRUMENT LOGS PROVIDED BY THE CUSTOMER. THE REVIEW DETERMINED THAT THERE WERE NO ERROR MESSAGES, EQUIPMENT FAULTS, OR OTHER ABNORMALITIES ENCOUNTERED ON THE SYSTEM DURING THE INCUBATION PERIOD OF LISTED BOTTLES THAT COULD HAVE CONTRIBUTED TO FALSE POSITIVE RESULTS. THE BOTTLE GRAPHS DO NOT SHOW TEMPERATURE RELATED PATTERNS. NO LOADING EVENTS OF NEW COLD BOTTLES NEAR THE BOTTLES INCUBATING AND LATER DECLARED POSITIVE, HAVE BEEN IDENTIFIED. NO TEMPERATURE-RELATED OR POWER-RELATED ALARMS OCCURRED FOR THE DATE RANGE ASSOCIATED WITH THE FALSE POSITIVE BOTTLES. TO CONCLUDE, THE REVIEW OF THE BACKUP DATA PROVIDED BY THE CUSTOMER DID NOT IDENTIFY ANY DEFINITIVE ROOT CAUSES FOR THE FALSE POSITIVE RESULTS. THERE WERE NO OPERATOR ERRORS, POWER FAULTS, TEMPERATURE FAULTS, OR OTHER ABNORMALITIES DURING INCUBATION OF BOTTLES PAV4T456, PAV4T9LT, PAV4T8NM, PAV4T7W6 AND PAV4T7SL. BIOMÉRIEUX CAN NOT EXCLUDE A CONTRIBUTION OF SAMPLE AS THE SLOW INCREASE IN REFLECTANCE VALUES AFTER LOADING OBSERVED IN THE BOTTLE GRAPHS IS CONSISTENT WITH POSSIBLE SAMPLE-RELATED FALSE POSITIVE RESULTS. PLEASE NOTE THAT THESE BOTTLE GRAPHS ARE INDISTINGUISHABLE FROM TRUE POSITIVE, THUS CUSTOMER MUST SUBCULTURE ALL POSITIVE BOTTLES TO CONFIRM RESULTS. THE BACT/ALERT® VIRTUO INSTRUMENT AT THE CUSTOMER¿S SITE PERTAINING TO THIS INVESTIGATION SHOWED NO MALFUNCTION. BACT/ALERT BPA CULTURE BOTTLE LOT 0001059651 BATCH RECORD REVIEW DID NOT SHOW ANOMALY THAT COULD BE RELATED TO THE FALSE POSITIVE REPORTED BY CUSTOMER. BACT/ALERT BPA CULTURE BOTTLE LOT 0001059651 EXPIRED ON 14DEC2023. COMPLAINT TRENDS: A 12-MONTH (24OCT2022 TO 29JAN2024) COMPLAINT SEARCH WAS PERFORMED FOR FALSE POSITIVE RESULTS WITH ¿AREA UNDER THE CURVE¿ ALGORITHM. THE COMPLAINT SEARCH RETURNED A TOTAL OF (B)(6) COMPLAINTS, INCLUDING THIS CUSTOMER¿S COMPLAINT. AMONG THE REMAINING FOUR (4) COMPLAINTS, TWO (2) OF THEM WERE IDENTIFIED TO BE ASSOCIATED WITH INSTRUMENTS NEAR FULL CAPACITY AND WERE CLOSED WITHOUT INVESTIGATION AFTER RECOMMENDATIONS WERE PROVIDED TO THE CUSTOMER. ONE (1) COMPLAINT IS CURRENTLY UNDER INVESTIGATION HOWEVER GICS EVALUATED GRAPH AND BELIEVE THEY ARE RELATED TO TEMPERATURE FALSE POSITIVE RESULTS. THE REMAINING ONE (1) COMPLAINT IS CURRENTLY UNDER TROUBLESHOOTING, GICS HAS IDENTIFIED THE MOST LIKELY ROOT CAUSE OF THE FALSE-POSITIVE RESULTS OBSERVED BY THE CUSTOMER, NAMELY THE LOADING OF NEW BOTTLES INTO CELLS THAT WERE IN CLOSE PROXIMITY TO BOTTLES UNDER INCUBATION, RESULTING IN A CHANGE IN THE BOTTLES' REFLECTANCE VALUES. A COMPLAINT SEARCH WAS PERFORMED FOR ALL COMPLAINTS AGAINST BPA BOTTLE LOT 0001059651 RETURNING ONLY THIS ONE (1) COMPLAINT ASSOCIATED WITH THE INVESTIGATION. RETAINS: NO REQUIREMENT FOR TESTING OF RETAINED CULTURE BOTTLES FOR BACT/ALERT® BPA LOT 0001059651. FALSE POSITIVE RESULTS OCCURRED WITH INOCULATED CULTURE BOTTLES. CONCLUDE PRODUCT COMPLIANCE TO SPECIFICATION/PERFORMANCE: THERE IS NO EVIDENCE OF ANY BOTTLE MALFUNCTION WITH THE BACT/ALERT® BPA CULTURE BOTTLE LOT 0001059651. MONITORING AND DETECTION METHODS FOR BOTTLE DEFECTS ASSOCIATED WITH POTENTIAL FALSE POSITIVE RESULTS ARE PART OF THE MANUFACTURING AND QUALITY CONTROL PROCESSES FOR BACT/ALERT® CULTURE BOTTLES. FALSE POSITIVES ARE AN INHERENT RISK OF THE CULTURE TEST AS NOISE IN THE GRAPH FROM VARIOUS SOURCES CAN TRIGGER A FALSE POSITIVE RESULT.

    Description of Event or Problem · 0

    INTENDED USE: BACT/ALERT® BPA CULTURE BOTTLES ARE USED WITH BACT/ALERT® MICROBIAL DETECTION SYSTEMS (BACT/ALERT® 3D AND BACT/ALERT® VIRTUO®) FOR QUALITY CONTROL TESTING OF LEUKOCYTE-REDUCED APHERESIS PLATELET (LRAP) UNITS, BOTH SINGLE AND POOLS OF UP TO SIX (6) UNITS OF LEUKOCYTE-REDUCED WHOLE BLOOD PLATELET CONCENTRATES (LRWBPC), AND POOLS OF UP TO FOUR (4) UNITS OF LEUKOCYTE REDUCED WHOLE BLOOD DERIVED BUFFY COAT PLATELETS (LRWBDBCP). BACT/ALERT® BPA CULTURE BOTTLES SUPPORT THE GROWTH OF AEROBIC MICROORGANISMS (BACTERIA AND FUNGI). ISSUE DESCRIPTION: A BLOOD BANK CUSTOMER IN CROATIA (CROATIAN INSTITUTE FOR TRANSFUSION MEDICINE) NOTIFIED BIOMÉRIEUX THAT THEY OBTAINED FALSE POSITIVE RESULTS FOR TWO BLOOD CULTURE BOTTLES THAT WERE LOADED AT THE SAME TIME, IN ASSOCIATION WITH THE BACT/ALERT BPA EU (REF 279044). AT THE TIME OF THIS ASSESSMENT, NO LOT NUMBER HAS BEEN PROVIDED. THERE IS NO INDICATION OR REPORT FROM THE CUSTOMER THAT THIS EVENT LED TO OR CONTRIBUTED TO DEATH, SERIOUS INJURY, OR SERIOUS DETERIORATION IN THE STATE OF HEALTH OF ANY PATIENT. THE BACT/ALERT BPA EU BOTTLE (REF 279044) IS NOT MARKETED OR SOLD IN THE UNITED STATES. HOWEVER THERE IS A UNITED STATES SPECIFIC EQUIVALENT PRODUCT, BACT/ALERT BPA US (REF: (B)(4), 510K: BK200472).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1727111 BACT/ALERT BPA EU - 279044 BACT/ALERT BPA EU - 279044 MZC BIOMÉRIEUX INC. 0001059651

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown