BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BACT/ALERT BPN US

    MDR report key: 16276337 · Received February 1, 2023

    Report

    Report Number
    3002769706-2023-00001
    Event Type
    Malfunction
    Date Received
    February 1, 2023
    Report Date
    June 27, 2023
    Manufacturer
    BIOMÉRIEUX, INC
    Product Code
    MZC
    UDI-DI
    03573026611323
    PMA / PMN Number
    BK050043
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONTEXT:A BLOOD BANK CUSTOMER IN THE UNITED STATES NOTIFIED BIOMÉRIEUX OF INSTRUMENT FALSE POSITIVE RESULTS WITH PLASMA PLATELETS SAMPLE IN ASSOCIATION WITH BACT/ALERT BPA US (REF. 423278, BATCH NUMBER 0001058875, EXPIRATION DATE 5/26/2023). THIS COMPLAINT IS RELATED TO THE COMPLAINT CN-454181 (SAME CUSTOMER, SAME ISSUE, DIFFERENT PRODUCT : BACT/ALERT BPN BOTTLE).THE CUSTOMER PERFORMED SUBCULTURE, WHICH WERE NEGATIVE AND GRAM STAINING WAS ALSO NEGATIVE.INVESTIGATION:** BATCH HISTORY RECORD AND COMPLAINT TREND ANALYSIS**THERE IS NO CAPA RELATED TO THE CUSTOMER¿S COMPLAINT RECORDED. A COMPLAINT HISTORY REVIEW WAS COMPLETED FOR THIS ISSUE CONCLUDED WITH NO IMPLICATION OF A TREND. THIS COMPLAINT HAS NOT BEEN IDENTIFIED AS A SYSTEMIC QUALITY ISSUE.**INVESTIGATION RESULTS**THE MANUFACTURING AND ACCEPTABLE QUALITY LIMIT (AQL) RECORDS FROM THE LOT NUMBERS REPORTED FOR CASES 3158758 AND 31532841 (BACT/ALERT® BPN LOT NUMBER 0001058889 AND BPA LOT NUMBER 0001058875, RESPECTIVELY) WERE EXAMINED BY BIOMÉRIEUX GLOBAL INDUSTRY CUSTOMER SERVICE (GICS) FOR ANY INDICATIONS OF ROOT CAUSES FOR FALSE POSITIVES RELATED TO THE MANUFACTURING OF THE BOTTLES. THERE WERE NO INDICATIONS OF A LOSS OF CONTROL IN THE AQL OR QC TESTING RECORDS FOR THE BATCHES, AND NO DISCREPANCIES WERE FOUND IN THE SAMPLING THAT WERE RELATED TO POSITIVE BOTTLES, OR THAT SUGGEST ANY ABNORMALITIES OCCURRED DURING THE PRODUCTION RUNS. A ROOT CAUSE FOR FALSE POSITIVES COULD NOT BE ATTRIBUTED TO THE PRODUCTION OF BOTTLE LOT NUMBERS 0001058889 OR 0001058875.THE GICS PART 2 INVESTIGATOR REVIEWED THE DATA PROVIDED BY THE CUSTOMER REGARDING THE OCCURRENCE OF FALSE POSITIVE RESULTS IN COMBINATION WITH THE BACKUP PROVIDED BY THE CUSTOMER FOR CONTRIBUTING FACTORS AND ROOT CAUSES FOR THE POSITIVE EVENTS. THE CUSTOMER PROVIDED THE BACKUP FROM THE FIRST CONTROLLER MODULE (008CM9665), WHICH ONLY CONTAINS BOTTLE DATA FROM 30DEC2023 UNTIL THE DATE THAT THE BACKUP WAS COLLECTED, 18JAN2023, DUE TO THE SIZE LIMITATIONS OF THE BACKUP FILE (THE BACT/ALERT® 3D BACKUP IS ONLY ABLE TO STORE RESULTS FROM THE MOST RECENT 1,920 BOTTLES). THEREFORE, THE BACKUP REVIEW COULD ONLY BE PERFORMED FOR BOTTLES WITHIN THIS TIME RANGE. ACCORDING TO THE DATA FOR THE POSITIVE RESULTS (FROM 30MAR2023), THE CUSTOMER HAS ENCOUNTERED FALSE POSITIVE RESULTS ON THIS CONTROLLER MODULE AND ASSOCIATED INCUBATION MODULES TWICE WITHIN THIS TIMEFRAME, ON 16JAN2023 AND 17DEC2022. HOWEVER, SINCE THE BACKUP WAS COLLECTED BEFORE THE BOTTLE TESTED ON 17JAN2023 FINISHED THE TEST, ONLY THE RESULTS FROM THE FALSE POSITIVE BOTTLE TESTED ON 16JAN2023 COULD BE REVIEWED.USING THE DATE AND TIME TESTED, THE POSITIVE RESULT STATUS IN THE BOTTLE REPORT, AND THE ACCESSION NUMBER LISTED IN THE DATA PROVIDED BY THE CUSTOMER, THE FALSE POSITIVE BOTTLE WAS IDENTIFIED AS BOTTLE ID PNVNR9PC. BOTTLE PNVNR9PC WAS LOADED ON 16JAN2023 AT 0925 LOCAL TIME INTO CELL 2B50 OF INCUBATION MODULE 007IRB609. THE BOTTLE WAS DETERMINED POSITIVE BY THE ACCELERATION ALGORITHM (HOW 2) ON 16JAN2023 AT 1613 LOCAL TIME FOR A TOTAL INCUBATION TIME OF 6.83 HOURS. THE BOTTLE WAS THEN UNLOADED WITHIN ONE MINUTE OF THE POSITIVE STATUS, AT 1613 ON 16JAN2023. RESULTS FROM THE CUSTOMER¿S DATA STATE THAT THE SUBCULTURE RESULTS FROM THE TESTING WAS NEGATIVE, HOWEVER THE GRAM STAIN PERFORMED BY THE CUSTOMER WAS FOUND TO HAVE GRAM POSITIVE ORGANISMS PRESENT.THE DATA IN THE BACKUP WAS EXAMINED FOR ANY ERRORS DURING THE DURATION OF THE INCUBATION OF BOTTLE PNVNR9PC THAT MAY INDICATE A ROOT CAUSE. THERE WERE NO TEMPERATURE, POWER, MODULE, OR OPERATOR ERRORS PRESENT DURING THIS TIME, THEREFORE THE SYSTEM IS CONSIDERED TO BE OPERATING WITHIN A STATE OF CONTROL, AND NO ROOT CAUSE COULD BE ASSOCIATED WITH THE INSTRUMENT, OPERATORS, OR ENVIRONMENT.A REVIEW OF THE BOTTLE GRAPH FROM BOTTLE PNVNR9PC SHOWS THAT THE REFLECTANCE VALUES BEGAN TO INCREASE AFTER THE INITIAL LOADING, WHICH IS EXPECTED FOR MOST BOTTLES DUE TO THE INCREASE IN TEMPERATURE OF THE BOTTLE AND SENSOR, AND THE SUBSEQUENT INCREASE IN REFLECTANCE VALUES. AT APPROXIMATELY 13 READINGS (APPROXIMATELY 2.16 HOURS) INTO INCUBATION, THE REFLECTANCE VALUES BEGIN TO DECREASE, FOLLOWED BY A STEADY INCREASE APPROXIMATELY 30 MINUTES LATER, CONTINUING UNTIL THE BOTTLE WAS DETERMINED POSITIVE AT 1613 LOCAL TIME ON 16JAN2023. ACCORDING TO THE BACKUP DATA, THE DECREASE IN REFLECTANCE VALUES FOR BOTTLE PNVNR9PC CORRESPONDS WITH A LOADING EVENT OF BOTTLE PNVNR915 ON 16JAN2023 AT 11:41 LOCAL TIME INTO CELL 2B49, ADJACENT TO THE CELL 2B50 IN WHICH THE FALSE POSITIVE BOTTLE WAS LOADED. ALTHOUGH IT COULD NOT BE DETERMINED TO BE THE DEFINITIVE ROOT CAUSE, THE LOADING OF A BOTTLE INTO THE ADJACENT CELL MAY CAUSE A DECREASE IN TEMPERATURE AND REFLECTANCE, WHICH MAY RESULT IN A HIGHER CHANCE OF A POSITIVE RESULT.THE AUDIT TRAIL PRESENT IN THE BACKUP DATA FROM CONTROLLER MODULE 008CM9665 CONTAINS THE HISTORY OF ACTIONS ON THE SYSTEM DATING BACK TO 13NOV2023. ALTHOUGH BOTTLE READINGS WERE UNABLE TO BE REVIEWED PRIOR TO 30DEC2023 DUE TO THE LIMITATION OF 1,920 BOTTLES, THE AUDIT TRAIL DATA (13NOV2023-18JAN2023) WAS REVIEWED FOR ANY ABNORMALITIES, SUCH AS TEMPERATURE EXCURSIONS, OPERATOR ERRORS, POWER OR MODULE FAULTS, THAT OCCURRED FROM 13NOV2023 TO THE DATE OF COLLECTION OF THE BACKUP ON 18JAN2023. THE RESULTS FROM THE REVIEW DETERMINED THAT NO TEMPERATURE FAULTS OR POWER FAILURES OCCURRED DURING THIS PERIOD. HOWEVER, THERE ARE EXAMPLES OF OPERATOR ERRORS, SUCH AS THE UNEXPECTED UNLOADING OF BOTTLES FROM THE SYSTEM (ERROR 911), AS WELL AS ERROR CODES FOR LOADING BOTTLES INTO CELLS UNDERGOING QC OR CELLS THAT HAVE BEEN DISABLED (ERROR 81, 99, AND 62). ADDITIONALLY, THERE ARE ERROR CODES PRESENT DURING THIS TIME THAT SHOW THE DRAWER IS PERIODICALLY OPENED FOR >2 MINUTES, INDICATED BY THE MODULE FAULT CODE 20 IN THE DATA. ALTHOUGH THERE ARE FAULTS WITHIN THE DATE RANGE EVALUATED, NONE OF THE ERROR CODES CORRESPOND TO THE FALSE POSITIVE RESULTS INDICATED IN THE DATA FOR THIS BACT/ALERT® 3D CONTROLLER MODULE.THE BACT/ALERT® 3D USER MANUAL AND INSTRUCTIONS FOR USE (IFU) OF THE BPN AND BPA BOTTLE TYPES CONTAIN STATEMENTS ON AVOIDANCE OF FALSE POSITIVE RESULTS, WHICH RECOGNIZE THE INHERENT RISK OF ENCOUNTERING FALSE POSITIVES ON THE SYSTEM. THE ANALYSIS OF THE POSITIVE BOTTLE TRENDING DATA PROVIDED BY THE CUSTOMER, AS WELL AS THE ASSOCIATED BACKUP DATA COLLECTED FROM THE SYSTEM, DETERMINED THAT THE MOST PROBABLE ROOT CAUSES MAY BE ASSOCIATED WITH FOUR KNOWN SOURCES OF FALSE POSITIVE RESULTS IDENTIFIED IN THESE RESOURCES. FIRST, THE SAMPLE TESTED USING THE BOTTLES IS IDENTIFIED AS BLOOD PLATELETS, WHICH ARE KNOWN TO MIMIC MICROBIAL GROWTH IN BACT/ALERT® BOTTLES WHEN THE SAMPLE IS INSUFFICIENTLY REDUCED OF LEUKOCYTES. SECOND, THE HIGH FREQUENCY OF LOADING AND UNLOADING OF BOTTLES (>100 BOTTLES ON EACH SYSTEM PER DAY) MAY INCREASE THE POTENTIAL OF TEMPERATURE-RELATED FALSE POSITIVE RESULTS DUE TO THE POSSIBILITY OF TEMPERATURE EXCURSIONS (THIS IS THE POTENTIAL ROOT CAUSE FOR BOTTLE PNVNR9PC). THIRD, SINCE THE CUSTOMER IDENTIFIED IN THE TRENDING DATA THAT AT LEAST FOUR FALSE POSITIVE RESULTS WERE ASSOCIATED WITH CELL 1B59 ON INCUBATOR 306IR5055 (CONTROLLER MODULE 306CM4041), CELL NOISE OR CALIBRATION WITHIN CELL 1B59 IN THIS INCUBATOR MAY BE A CONTRIBUTING FACTOR TO SOME OF THE FALSE POSITIVE RESULTS WITHIN THIS CELL. FINALLY, IT IS POSSIBLE THAT SOME OF THE RESULTS LISTED AS FALSE POSITIVES WERE TRUE POSITIVES, AS THE CUSTOMER¿S GRAM STAIN WAS POSITIVE FOR SOME SAMPLES, WHILE THE CORRESPONDING SUBCULTURE WAS NEGATIVE. THE BACT/ALERT® BPN AND BPA BOTTLE INSTRUCTIONS FOR USE RECOGNIZE THE POSSIBILITY THAT SOME MICROORGANISMS MAY NOT GROW ON GENERIC SUBCULTURING MEDIA, AND RECOMMENDS ADDITIONAL SPECIALIZED SUBCULTURE MEDIA IF THIS IS SUSPECTED. (REFER TO IFUS FOR 423278 AND 423279, REAGENTS SECTION, CAUTIONARY STATEMENTS).OVERALL, THE RATE OF FALSE POSITIVE RESULTS AT THE CUSTOMER BASED ON THE AVAILABLE DATA IN THE CASES IS TWO (2) BOTTLES OUT OF 1,920 TOTAL BOTTLES. THIS IS ESTIMATED AS THE NUMBER OF BOTTLES IDENTIFIED IN THE BACKUP FROM CONTROLLER MODULE 008CM9665 AND THE DATE RANGE OF 30DEC2022-18JAN2023 (1,920 BOTTLES) IN COMPARISON TO THE CUSTOMER¿S DATA, WHICH IDENTIFIES ONLY TWO POSITIVE BOTTLES, TESTED ON 16JAN2023 AND 17JAN2023. THIS ESTABLISHES A FALSE-POSITIVE RATE OF APPROXIMATELY 0.1%.CONCLUDE PRODUCT COMPLIANCE TO SPECIFICATION/PERFORMANCE:THERE IS NO EVIDENCE OF ANY BOTTLE MALFUNCTION OF THE BACT/ALERT® BPA OR BPN CULTURE BOTTLE LOTS. THE LOT NUMBERS 0001058889 AND 0001058875 ASSOCIATED WITH THIS CASE MET ALL QUALITY RELEASE CRITERIA, AND TRENDING OF THE BOTTLE TYPE AND LOT NUMBERS DID NOT DETERMINE A TREND FOR FALSE POSITIVE RESULTS WAS PRESENT. ADDITIONALLY, THE BACKUP ANALYSIS OF THE BACT/ALERT® 3D SYSTEM DID NOT IDENTIFY ANY ABNORMALITIES OCCURRED ON THE SYSTEM THAT CONTRIBUTED TO THE FALSE POSITIVE RESULTS, AND THE SYSTEM IS CONFIRMED TO BE OPERATING WITHIN SPECIFICATIONS BASED ON THE REVIEW.

    Description of Event or Problem · 0

    INTENDED USE: BACT/ALERT® BPN 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, AND BOTH SINGLE AND POOLS OF UP TO SIX (6) UNITS OF LEUKOCYTE-REDUCED WHOLE BLOOD PLATELET CONCENTRATES (LRWBPC). BACT/ALERT® BPN CULTURE BOTTLES SUPPORT THE GROWTH OF ANAEROBIC AND FACULTATIVE ANAEROBIC MICROORGANISMS (BACTERIA). ISSUE DESCRIPTION: A BLOOD BANK CUSTOMER IN THE UNITED STATES NOTIFIED BIOMÉRIEUX OF INSTRUMENT FALSE POSITIVE RESULTS WITH PLASMA PLATELETS SAMPLE IN ASSOCIATION WITH BACT/ALERT BPN US (REF. (B)(4), BATCH NUMBER 0001058889, EXPIRATION DATE 1-JUN-2023). THIS COMPLAINT IS RELATED TO THE COMPLAINT CN-456118 (SAME CUSTOMER, SAME ISSUE, DIFFERENT PRODUCT : BACT/ALERT BPA BOTTLE). THE CUSTOMER PERFORMED SUBCULTURE, WHICH WERE NEGATIVE AND GRAM STAINING WAS ALSO NEGATIVE. THIS CASE IS SIMILAR TO A PRIOR CASE IN (B)(6) 2022 (CN-354152) WHERE THE ROOT CAUSE WAS UNABLE TO BE DETERMINED DEFINITIVELY, BUT IT IS LIKELY ASSOCIATED WITH THE SAMPLE TYPE (LEUKOCYTE-REDUCED PLATELETS). BIOMÉRIEUX GLOBAL INDUSTRY CUSTOMER SERVICE (GICS) WILL REVIEW THE DETAILS PROVIDED BY THE CUSTOMER TO DETERMINE IF THE MOST RECENT DATA IS WITHIN THE EXPECTED VALUES IN THE IFU. ALTHOUGH THE CUSTOMER INDICATED THAT SOME OF THE PRODUCTS HAVE BEEN TRANSFUSED, THERE IS NO INDICATION OR REPORT FROM THE LABORATORY THAT THE POTENTIAL FALSE POSITIVE RESULTS LED TO ANY ADVERSE EVENT RELATED TO ANY PATIENT'S STATE OF HEALTH. AN INVESTIGATION HAS BEEN INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1301145 BACT/ALERT BPN US BACT/ALERT BPN US MZC BIOMÉRIEUX, INC 0001058889 03573026611323

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown