BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BACT/ALERT BPN

    MDR report key: 15396527 · Received September 9, 2022

    Report

    Report Number
    3002769706-2022-00040
    Event Type
    Malfunction
    Date Received
    September 9, 2022
    Report Date
    April 14, 2023
    Manufacturer
    BIOMÉRIEUX, INC
    Product Code
    MZC
    PMA / PMN Number
    BK050043
    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 A FALSE POSITIVE RESULT FOR A PLATELET CONCENTRATE SAMPLE IN ASSOCIATION WITH THE BACT/ALERT® BPN EU (REF 279045, LOT 0001058033). ---INVESTIGATION--- COMPLAINT TREND ANALYSIS: GLOBAL CUSTOMER SERVICE (GCS) PERFORMED A COMPLAINT TREND ANALYSIS AND DID NOT IDENTIFY THE CUSTOMER'S ISSUE AS A TREND FOR THE BACT/ALERT BPN EU. DATA REVIEW: THE PRIMARY INVESTIGATOR REQUESTED A REVIEW OF THE BOTTLE GRAPHS FROM BIOMATH FOR THE BOTTLE ASSOCIATED WITH THIS CASE. BIOMATH'S ALGOTOOL FLAGGED THE BOTTLE POSITIVE FROM THE BOTTLE READINGS EXTRACTED FROM THE BACKUP, AND THE TIME-TO-DETECTION MATCHES THE INSTRUMENT RESULTS. THE REFLECTANCE CURVE FOR THE BOTTLE IS NOT CONSISTENT WITH THE PRESENCE OF MICROORGANISMS BASED ON THE REVIEW. ADDITIONAL INFORMATION PROVIDED: LOCAL CUSTOMER SERVICE (LCS) PROVIDED ADDITIONAL INFORMATION RELEVANT TO POSSIBLE ROOT CAUSES FOR THE FALSE-POSITIVE BOTTLE. ACCORDING TO THE CUSTOMER-PROVIDED INFORMATION, THE BOTTLE WAS CONFIRMED TO BE NEGATIVE FROM SUBCULTURING PERFORMED BY AN EXTERNAL LABORATORY. THERE WERE NO ABNORMALITIES REPORTED FOR THE BOTTLE, AND THE SENSOR COLOR WAS REPORTED AS GREY BEFORE USE. THE BOTTLE WAS STATED TO BE STORED AT ROOM TEMPERATURE. THERE WAS NO DELAYED ENTRY REPORTED FOR THE BOTTLE. THE SYSTEM WAS STATED TO BE LOCATED AWAY FROM ANY SOURCE OF TEMPERATURE CHANGES, SUCH AS VENTS OR AIR DUCTS. FINALLY, THE BACT/ALERT® 3D INCUBATORS (36°C AND 31°C) ARE STATED TO BE LOCATED ON SEPARATE, INDEPENDENT CIRCUITS, AND NO POWER FAULTS OR OTHER ERRORS WERE REPORTED IN THE CASE DETAILS. RETAIN EVALUATION: NO RETAINS WERE EXAMINED AS THE COMPLAINT IS NOT RELATED TO A VISUAL DEFECT. INSTRUCTIONS FOR USE (IFU) REVIEW: THE INSTRUCTIONS FOR USE (IFU) FOR THE BPN EU BOTTLES WERE REVIEWED TO DETERMINE IF THE INSTRUCTIONS PROVIDE ADEQUATE GUIDANCE FOR THE USE OF BACT/ALERT® BPN EU BOTTLES, SPECIFICALLY IN THE AVOIDANCE OF FALSE-POSITIVE EVENTS. BASED ON THE REVIEW, ADEQUATE PREVENTATIVE MEASURES FOR AVOIDING FALSE POSITIVE RESULTS ARE STATED IN THE IFUS, SUCH AS SUPPORTED INOCULATION METHODS, MAXIMUM FILL VOLUMES, BOTTLE STORAGE TEMPERATURES, VISUAL INSPECTION OF BOTTLE MEDIA AND SENSORS BEFORE AND AFTER INCUBATION, AND CONFIRMATION OF RESULTS USING GRAM STAINING AND SUB-CULTURING TECHNIQUES IN THE EVENT OF A POSITIVE RESULT. ADDITIONALLY, THE BACT/ALERT® 3D USER MANUAL PROVIDES RECOMMENDATIONS FOR MANUALLY REDUCING THE OCCURRENCES OF FALSE-POSITIVE RESULTS WITH BACT/ALERT® CULTURE BOTTLES, SUCH AS SAMPLE COMPOSITION, SAMPLE VOLUME, LOADING/UNLOADING BOTTLES, AND TEMPERATURE CHANGES IN THE LABORATORY ENVIRONMENT. INSTRUMENT-RELATED FALSE POSITIVES ARE ALSO DESCRIBED TO AID THE CUSTOMER IN TROUBLESHOOTING THE CAUSES OF CELL NOISES AND HIGH INITIAL READINGS. REFER TO THE BACT/ALERT® 3D USER MANUAL (REFERENCE (B)(4)), APPENDIX C, FOR SPECIFIC PREVENTATIVE MEASURES. ROOT CAUSE: THE BOTTLE READINGS FOR BOTTLE (B)(6) WERE LOADED INTO THE GICS ALGORITHM TOOL FOR REVIEW. THE ALGORITHM TOOL CONFIRMED THAT THE BOTTLE WAS POSITIVE DUE TO THE ACCELERATION ALGORITHM USING ALGORITHM 11 (FOR PLATELET PRODUCTS) . THE GRAPH DOES NOT APPEAR TO SHOW A RAPID, EXPONENTIAL CHANGE IN REFLECTANCE CONSISTENT WITH THE GROWTH OF MICROORGANISMS, HOWEVER THE GRAPH SHOWS A SHIFT IN THE REFLECTANCE READINGS ON (B)(6) 2022, APPROXIMATELY 8 HOURS PRIOR TO THE POSITIVE RESULT. THE BACKUP DATA FROM THE BACT/ALERT® 3D INSTRUMENT WAS REVIEWED FOR EVENTS WITHIN THE INCUBATION TIME OF BOTTLE (B)(6) THAT MAY HAVE CONTRIBUTED TO THE POSITIVE STATUS OF THE BOTTLE. NO TEMPERATURE, POWER, OR OTHER FAULTS OCCURRED ON THE SYSTEM DURING THE INCUBATION PERIOD THAT WOULD HAVE CONTRIBUTED TO THE POSITIVE STATUS. HOWEVER, AT APPROXIMATELY 03:28 GMT, FOUR BOTTLES WERE LOADED INTO CELLS 1A03, 1A04, 1A13 AND 1A12, WHICH ARE IMMEDIATELY ADJACENT TO CELL 1A02 CONTAINING BOTTLE (B)(6). THE ROOT CAUSE MAY BE RELATED TO THE LOADING EVENTS OCCURRING ADJACENT TO THE BOTTLE DURING INCUBATION, AS EXISTING LOADED BOTTLES ARE SUSCEPTIBLE TO CHANGE IN READINGS DUE TO A SUBSEQUENTLY LOADED BOTTLE. MANUFACTURING RECORD REVIEW: A REVIEW OF THE MANUFACTURING RECORDS FOR THE LOT NUMBER ASSOCIATED WITH THIS INVESTIGATION WAS NOT REQUIRED, AS TRENDING OF COMPLAINTS FOR THE ASSOCIATED LOT NUMBER (0001058033) DID NOT ESTABLISH AN ADVERSE TREND. ALSO, THE INVESTIGATION DID NOT FIND THAT THE BACT/ALERT BOTTLES HAD ANY EVIDENCE OF MALFUNCTION AS THE ROOT CAUSE (FOR EXAMPLE, PLASTIC BOTTLE OR SENSOR DEFECTS). THE CSTAT TRENDING FOR THE FALSE-POSITIVES PROVIDES EVIDENCE THAT THE MANUFACTURING OF THE BACT/ALERT® BPN EU, IS IN A STATE OF CONTROL, AS NO ADVERSE TREND WAS DETERMINED BASED ON THE REVIEW. THE DETAILS IN THE CASE, AS WELL AS THE ANALYSIS OF THE BOTTLE DATA FROM BIOMATH, SUGGEST THAT THE ROOT CAUSE IS UNLIKELY TO BE ASSOCIATED WITH THE MANUFACTURING OF THE BACT/ALERT® BOTTLES, THEREFORE A REVIEW OF THE PRODUCTION RECORDS WAS NOT PERFORMED. ---CONCLUSION--- THE INVESTIGATION CONCLUDED THAT THERE IS NO INDICATION OF A PRODUCT PROBLEM FOR THE BACT/ALERT BPN EU BOTTLE. THE ROOT CAUSE FOR THE FALSE POSITIVE RESULT MAY BE RELATED TO THE LOADING EVENTS OCCURRING ADJACENT TO THE BOTTLE DURING INCUBATION, AS EXISTING LOADED BOTTLES ARE SUSCEPTIBLE TO CHANGE IN READINGS DUE TO A SUBSEQUENTLY LOADED BOTTLE.

    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, 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® BPN CULTURE BOTTLES SUPPORT THE GROWTH OF ANAEROBIC AND FACULTATIVE ANAEROBIC MICROORGANISMS (BACTERIA). DESCRIPTION: A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF OBTAINING A FALSE POSITIVE RESULT FOR A PLATELET CONCENTRATE SAMPLE IN ASSOCIATION WITH THE BACT/ALERT® BPN EU REF:(B)(4), LOT: 0001058033). THE CUSTOMER REPORTED THAT THE SAMPLE TESTED NEGATIVE FOR GROWTH BY AN EXTERNAL LABORATORY. THE BOTTLE WAS INSPECTED PRIOR TO LOADING IN THE INSTRUMENT AND THERE WERE NO ANOMALIES IDENTIFIED. THE SENSOR COLOR PRIOR TO LOADING WAS GREY, INDICATING THAT THERE WAS NO DETECTABLE GROWTH AT THE TIME THE BOTTLE WAS LOADED. THERE IS NO INDICATION OR REPORT FROM THE CUSTOMER THAT THIS EVENT LED TO OR CONTRIBUTED TO ANY DEATH, SERIOUS INJURY, OR SERIOUS DETERIORATION IN THE STATE OF HEALTH FOR ANY PATIENT. THE BACT/ALERT BPN EU REF. (B)(4) ARE INDUSTRY ONLY PRODUCTS AND ARE NOT SOLD OR DISTRIBUTED IN THE UNITED STATES. HOWEVER, THE BACT/ALERT SN REF: (B)(4) IS AN EQUIVALENT PRODUCT THAT IS INTENDED FOR CLINICAL (IVD) USE AND APPROVED FOR USE IN THE UNITED STATES. INDUSTRY BACT/ALERT® BOTTLES CONTAIN THE SAME CULTURE MEDIUM FORMULATION AND ARE MANUFACTURED IN THE SAME LOT AS CLINICAL BACT/ALERT® CULTURE BOTTLES. AN INVESTIGATION HAS BEEN INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1708767 BACT/ALERT BPN BACT/ALERT BPN MZC BIOMÉRIEUX, INC 0001058033

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown