BACT/ALERT BPA EU 100 BTLS - 279044

Additional Manufacturer Narrative

SINCE THE PREVIOUS SUPPLEMENTAL EMDR WAS SUBMITTED, THE LOT NUMBERS RELATED TO THE CUSTOMER'S ORIGINAL COMPLAINT WAS UPDATED. THE PRODUCT REFERENCES AND LOT NUMBERS ARE AS FOLLOWS: BACT/ALERT BPA EU (B)(4) BTLS - (B)(6). (B)(4). BACT/ALERT BPN EU (B)(4) BTLS - (B)(6). (B)(4).

Description of Event or Problem

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 CUSTOMER IN AUSTRALIA NOTIFIED BIOMÉRIEUX OF OBTAINING FALSE NEGATIVE RESULT WHEN TESTING APHERESIS PLATELETS USING THE BACT/ALERT BPA EU 100 BTLS (REF (B)(4)). AT THIS TIME, THE CUSTOMER HAS NOT PROVIDED ANY LOT NUMBERS USED FOR TESTING. THE CUSTOMER REPORTED THAT THEY OBTAINED FALSE NEGATIVE RESULTS WITH THE BACT/ALERT BPA EU BOTTLES AT TWO OF THEIR SITES (SYDNEY AND PERTH). ALL TESTING WAS FOR APHERESIS PLATELETS AND THESE MAY BE SINGLE, DOUBLE OR TRIPLE COLLECTIONS DEPENDENT UPON THE COLLECTION VOLUME AND COUNT. THE CUSTOMER INDICATED THAT THEY DID SEE VISIBLE GROWTH IN PACKS AND GROWTH IDENTIFIED WHEN RECOVERED UNITS AND SAMPLES WERE TESTED AT AN EXTERNAL LABORATORY. THE BACT/ALERT BOTTLES WERE NEGATIVE ON VIRTUO AFTER 7 DAYS. THE CUSTOMER ISOLATED ORGANISMS FROM THE PACKS AND THE IDENTIFICATIONS WERE REPORTED AS MULTIPLE BACILLUS SPECIES. INFORMATION FROM SYDNEY SITE : PLATELET BAGS SCREENED NEGATIVE ON VIRTUO, ONE BOTTLE FOUND WAS SUBCULTURED AFTER HOSPITAL REPORTED INCIDENT AND NO GROWTH WAS SEEN FROM BOTTLE. PLATELET BAGS WERE ADMINISTERED TO TWO (2) PATIENTS. THE PATIENTS WERE TREATED WITH ANTIBIOTICS. THE CUSTOMER CONFIRMED THAT THE FALSE NEGATIVE BACT/ALERT RESULT DID NOT LEAD TO OR CONTRIBUTE TO DEATH OR SERIOUS INJURY FOR THE PATIENTS. THE PLATELET PACKS ALSO WERE CULTURED AND ISOLATED BACILLUS SPP. PLASMA UNITS WERE ALSO TESTED AND GREW B.CEREUS. MALDI-TOF OF HOSPITAL CULTURE AND PLASMA UNITS FOUND B.MOBILIS. AT THE TIME OF THE ASSESSMENT, NO FURTHER INFORMATION HAS BEEN PROVIDED REGARDING THE TYPE OF TESTING PERFORMED ON EACH SAMPLE. INFORMATION FROM PERTH SITE: LIFEBLOOD HAS BEEN NOTIFIED BY HOSPITALS THAT VISIBLE GROWTH IS PRESENT CULTURES OF THE PACKS (A&C). THE HOSPITALS DID NOT ADMINISTER PLATELET PACKS AFTER SEEING VISIBLE GROWTH OF TWO (2) PACKS. CUSTOMER INSPECTED ONE (1) RETENTION PACK WITH GROWTH BUT APPEARED SIMILAR TO NORMAL PLATELET AGGREGATES. ALL PACKS WERE SUBCULTURED AND FOUND B.CEREUS (ALL 3 PACKS) AND STAPH (IN 2 PACKS). CUSTOMER IS IN PROCESS OF TESTING ASSOCIATED PLASMA UNITS ON VIRTUO. THEY HAVE PLANED TO TEST ISOLATES ON MALDI-TOF. AN INVESTIGATION HAS BEEN INITIATED. NOTE: BACT/ALERT BPA EU 100 BTLS (REF (B)(4)) ARE NOT REGISTERED FOR USE IN THE UNITED STATES. HOWEVER THE BACT/ALERT BPA US (REF (B)(4)) IS A SIMILAR DEVICE REGISTERED FOR USE IN THE UNITED STATES.

Additional Manufacturer Narrative

AN INVESTIGATION WAS INITIATED IN RESPONSE TO A BLOOD BANK INDUSTRY CUSTOMER FROM AUSTRALIAN RED CROSS, LOCATED IN SYDNEY, AUSTRALIA. THE CUSTOMER NOTIFIED BIOMÉRIEUX THAT FALSE NEGATIVE RESULTS WITH BACILLUS SPP. SPECIES WERE OBTAINED DURING ROUTINE POOLED PLATELETS TESTING USING BACT/ALERT® BPA EU 100 BTLS - 279044 AND BACT/ALERT BPN EU 100 BTLS ¿ 279045. THE CUSTOMER ALSO REPORTED THEY HAD ANOTHER OCCURRENCE OF ALLEGED FALSE NEGATIVE RESULTS WITH BACILLUS CEREUS AND STAPHYLOCOCCUS EPIDERMIDIS IN THE PAST (WITH NO PATIENT INVOLVED) IN ANOTHER SITE IN AUSTRALIA, PERTH. INVESTIGATION: IMPLICATED LOTS: AT THE TIME OF THE COMPLAINT AND UNTIL THE INVESTIGATION CLOSURE DATE, INFORMATION ON BOTTLE LOT NUMBERS, THE EXACT TIMELINE OF THE EVENT, AVAILABILITY OF THE STRAIN AND THE VIRTUO LOGS WERE STILL NOT CONFIRMED BY THE CUSTOMER. SINCE NO FURTHER INFORMATION WAS PROVIDED BY THE CUSTOMER, THE SAP SHIPPING DATA WERE REVIEWED FOR LOTS RECEIVED BY AUSTRALIAN RED CROSS ¿ SYDNEY, DURING TIME FRAME OF THE EVENT (INDICATED TO BE DEC2023) AND THE LOTS THAT INVESTIGATORS ASSESSED TO BE LIKELY IN USE WERE IDENTIFIED AS BPA LOT 0001060334 AND BPN LOT 0001060367. THE SAP SHIPPING DATA WERE REVIEWED FOR LOTS RECEIVED RECENTLY BY AUSTRALIAN RED CROSS ¿ PERTH, AND THE LOTS THAT THE INVESTIGATORS ASSESSED AS LOTS THAT WERE LIKELY IN USE AT THE TIME OF THE FALSE NEGATIVE WERE IDENTIFIED TO BE BPA LOTS 0001060334 OR 0001060511, AND BPN LOTS 0001060503 OR 0001060367. COMPLAINT TREND ANALYSIS: GLOBAL CUSTOMER SERVICE (GCS) PERFORMED A COMPLAINT TREND ANALYSIS AND DID NOT IDENTIFY THE CUSTOMER'S ISSUES AS TRENDS FOR THE BACT/ALERT BPA EU OR THE BACT/ALERT BPN EU BOTTLES. MANUFACTURING RECORD REVIEW: THE BATCH RECORDS WERE REVIEWED FOR ANY ABNORMALITIES THAT COULD HAVE OCCURRED DURING THE MANUFACTURING, FILLING, AND PACKAGING PROCESS OF THE LOTS ALLEGEDLY IN USE AT CUSTOMER¿S SITES AT THE TIME OF THE FALSE NEGATIVE EVENT. THERE ARE NO EVENTS IN THE BULKING OR FILLING RECORDS THAT INDICATE AN ISSUE DURING LOTS MANUFACTURING. THERE WERE NO QUALITY EVENTS THAT COULD BE RELATED TO ALLEGED FALSE NEGATIVE RESULTS REPORTED BY THE CUSTOMER. IN CONCLUSION, THE FOUR BATCHES 0001060334, 0001060367, 0001060511 AND 0001060503 THAT COULD HAVE BEEN USED BY SYDNEY AND PERTH¿S SITE, MET THE CRITERIA FOR FINAL RELEASE. EXAMINATION OF THE BATCH RECORDS REVEALED NO MALFUNCTION RELATED TO MANUFACTURING OF ANY OF THE LOTS. FOR ALL FOUR LOTS, THE GROWTH PROMOTION TESTING PERFORMED AT BIOMÉRIEUX SHOWED THAT FOR EVERY ORGANISM TESTED, THE TIME OF DETECTION WAS WITHIN SPECIFICATION. NO DELAY OF DETECTION COULD BE OBSERVED. NONE OF THE LOTS NEEDED TO BE RETESTED AND NO INCIDENTS RECORDED DURING THE TESTS. ORGANISM RECOVERY PERFORMANCE DATA: AS PART OF THE INVESTIGATION, DATA PERTAINING THE RECOVERY OF THE ORGANISMS INVOLVED IN BOTH EVENTS OF ALLEGED FALSE NEGATIVE RESULTS AT SYDNEY¿S AND PERTH¿S SITES WERE COLLECTED FROM THE DIFFERENT DOCUMENTATION AVAILABLE AND REVIEWED. THE BPA AND BPN IFU PROVIDE INFORMATION ON DETECTION TIME OF BACILLUS CEREUS AND STAPHYLOCCOCUS EPIDERMIDIS IN BOTH BOTTLE TYPES. THE DETECTION TIME OF BACILLUS CEREUS STRAIN IS STATED TO BE LOWER THAN 14 HOURS AND OF STAPHYLOCOCCUS EPIDERMIDIS TO BE LOWER THAN 22 HOURS DURING TESTS PERFORMED BY BIOMÉRIEUX. THE OVERALL RECOVERIES OF THESE ORGANISMS IS VERY QUICK, AS WITHIN A DAY. ADDITIONAL DATA GENERATED DURING A PREVIOUS INVESTIGATION FROM 2022 WITH B. CEREUS IN BPA AND BPN BOTTLES CONFIRMED THE IFU STATEMENT. INDEED, THE RESULTS GENERATED THROUGH THE PREVIOUS INVESTIGATION SHOWED 100% INSTRUMENT POSITIVE RESULTS FOR ALL BOTTLES INOCULATED WITH THIS ORGANISM, WITH AN AVERAGE TIME TO DETECTION FOR ALL POSITIVE BOTTLES RANGING FROM 10.20 HOURS TO 15.29 HOURS. ALL THE DATA ARE INDICATING A QUICK AND CONSISTENT RECOVERY OF BACILLUS AND STAPHYLOCCOCUS SPECIES. INSTRUCTIONS FOR USE (IFU) REVIEW: THE INVESTIGATOR REVIEWED THE BACT/ALERT® BPA AEROBIC CULTURE BOTTLES (PART 279044) INSTRUCTIONS FOR USE AND BACT/ALERT® BPN ANAEROBIC CULTURE BOTTLES (PART 279045) INSTRUCTIONS FOR USE AND CONCLUDED THEY PROVIDE ADEQUATE GUIDANCE. ROOT CAUSE: THE MOST LIKELY ROOT CAUSES TO THE CUSTOMER¿S ISSUE ARE PLATELETS SAMPLE MISHANDLING OR SAMPLING ISSUE, IT IS POSSIBLE THE ORGANISM WAS PRESENT IN NUMBERS BELOW THE LIMIT OF DETECTION AT THE TIME OF SAMPLING, OR THAT THEY WERE INTRODUCED LATER IN THEIR PROCESS PRIOR TO TRANSFUSION. THESE HYPOTHESES COULD NOT BE CONFIRMED BY THE INVESTIGATION DUE TO LIMITED INFORMATION AND MATERIAL PROVIDED FOR THE INVESTIGATION PURPOSES. CONCLUSION: THE INVESTIGATION DID NOT IDENTIFY ANY PRODUCT PERFORMANCE ISSUES FOR THE BACT/ALERT® BPA EU 100 BTLS - 279044 AND BACT/ALERT BPN EU 100 BTLS ¿ 279045. DUE TO A LACK OF INFORMATION FROM THE CUSTOMER REGARDING THE EVENTS, NO DEFINITIVE ROOT CAUSE COULD BE ESTABLISHED FOR THE ALLEGED FALSE NEGATIVE RESULTS REPORTED IN THIS INVESTIGATION. PERFORMANCE ISSUE OF THE BOTTLES IS VERY UNLIKELY AS BIOMÉRIEUX DEMONSTRATED ON SEVERAL ATTEMPTS A GOOD RECOVERY OF BACILLUS / S. EPIDERMIDIS STRAINS IN BPA AND OR BPN BOTTLES AND THE GROWTH PROMOTION TESTS PERFORMED ON BOTTLES, DID NOT SHOW ANY ISSUE IS RECOVERY OF QUALITY CONTROL ORGANISMS.