BACT/ALERT BPN EU - 279045

Report

Report Number: 3002769706-2021-00018
Event Type: Malfunction
Date Received: June 30, 2021
Report Date: October 14, 2021
Manufacturer: BIOMERIEUX INC.
Product Code: MZC
PMA / PMN Number: BK050043
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: GM
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 0

AN INVESTIGATION WAS CONDUCTED FOR ONE CUSTOMER COMPLAINT FOR BACT/ALERT® INST CULTURE BOTTLE (PART NUMBER 259785), AND SEEDED STUDY PERFORMANCE OF CLOSTRIDIUM SPOROGENES. THE INVESTIGATION FOUND THAT THE ROOT CAUSE FOR DELAYED TIME TO DETECTION OR NO GROWTH WAS THE PRESENCE OF AIR INJECTED INTO THE BOTTLES DURING INOCULATION. THE ROOT CAUSE WAS DETERMINED BY REVIEWING A VIDEO MADE BY THE CUSTOMER OF INOCULATION OF ONE BOTTLE; AND INTERNAL TESTING PERFORMED BY BIOMÉRIEUX FOR THIS INVESTIGATION USING VARIOUS NEEDLE SIZES, ORGANISMS, INOCULATION WITH AND WITHOUT 10 ML OF SALINE. THE GROWTH ISSUE FOR C. SPOROGENES IS DUE TO THE ADDITIONAL INTRODUCTION OF OXYGEN IN THE BOTTLE DURING TESTING AT THE CUSTOMER SITE. MAINLY DUE TO THE SIZE OF NEEDLE GAUGE AND ADDITION OF 10 ML OF SALINE (THAT IS NOT DEGASSED OR PRE-REDUCED TO REMOVE OXYGEN). INVESTIGATION DATA SHOWED THE TIME TO DETECTION FOR CLOSTRIDIUM SPOROGENES, A STRICT ANAEROBE, INCREASES AS THE NEEDLE GAUGE INCREASES AND/OR 10 ML OF SALINE IS ADDED. THE TIME TO DETECTION FOR PSEUDOMONAS AERUGINOSA, A STRICT AEROBE, DECREASES AS THE NEEDLE GAUGE INCREASES AND/OR 10 ML OF SALINE IS ADDED. THIS SHOWS THE EFFECT OF NEEDLE GAUGE AND USE OF A 10 ML OXYGENATED SAMPLE CAN HAVE ON RECOVERY IN THE ANAEROBIC BOTTLE. AN INDEPENDENT RECENT PUBLICATION ALSO CONCLUDES A SMALLER NEEDLE SIZE IMPROVES PERFORMANCE: ¿USE OF 27G NEEDLES IMPROVES SENSITIVITY AND PERFORMANCE OF ATCC ANAEROBE REFERENCE MICROORGANISM DETECTION IN BACT/ALERT SYSTEM¿, PASQUA ET. AL., MOLECULAR THERAPY: METHODS & CLINICAL DEVELOPMENT, VOL. 20, MARCH 2021 © 2021 THE AUTHOR(S).THIS IS AN OPEN ACCESS ARTICLE UNDER THE CC BY LICENSE (HTTP://CREATIVECOMMONS.ORG/LICENSES/BY/4.0/). EXAMINATION OF THE CUSTOMER¿S TWO BACT/ALERT® 3D B.50 DATA BACKUPS SHOWED THAT THE POSITIVE BOTTLE GRAPHS HAD GOOD LOG PHASE GROWTH CURVES, WHILE THE NEGATIVE BOTTLES HAD FLAT GRAPHS CONSISTENT WITH A TRUE NEGATIVE. THERE WAS NO IMPACT OR HARM TO A PATIENT, AS TESTING WAS A SEEDED STUDY PERFORMED FOR VALIDATION PURPOSES OF NEW SAMPLE MATRICES. THE CUSTOMER REPORTED THEIR SEEDED STUDY ISSUES TO THE LOCAL COMPETENT AUTHORITY ALONG WITH THEIR INTERNAL INVESTIGATION EFFORTS. THE CUSTOMER ADDED FOUR LOT NUMBERS OF BACT/ALERT BPN BOTTLE TO THEIR REPEAT TESTING AS PART OF THEIR INTERNAL INVESTIGATION. THIS BOTTLE TYPE ALSO HAS NO ADVERSE TREND IN THE COMPLAINT OR MANUFACTURING DATA. THIS BOTTLE TYPE HAS A SPECIFIC INTENDED USE FOR PLATELET TESTING ONLY, BUT IS A PRODUCT EQUIVALENT FOR INST OUTSIDE OF INTENDED USE AND LABELING. THE BOTTLE INSTRUCTIONS FOR USE (IFU) FOR IAST AND BPN, WERE REVIEWED BY THE INVESTIGATOR. THE IFU FOR INST DOES SAY TO CONSIDER USING A 23 GAUGE NEEDLE OR SMALLER TO AVOID OXYGENATION. A TECHNICAL REVIEW OF THE IFU WAS PERFORMED TO MAKE CHANGES TO CLARIFY THAT USING A SMALLER GAUGE NEEDLE IS IMPORTANT AND CAN DIRECTLY IMPACT RECOVERY AND TIME TO DETECTION. THE BOTTLE INSTRUCTIONS FOR USE WILL BE UPDATED TO CLARIFY IMPORTANCE OF NEEDLE SIZE. THE IFU ALSO STATES: ¿ NO MORE THAN 10 ML OF SAMPLE SHOULD BE TESTED IN EACH BOTTLE. WHEN TESTING NON-NUTRITIONAL SAMPLES SUCH AS SUSPENSION IN WATER, THE SAMPLE VOLUME ADDED TO THE BOTTLE MAY NEED TO BE LESS THAN 10 ML. ¿ BACT/ALERT INST CULTURE BOTTLES CONTAIN AN ANAEROBIC ATMOSPHERE UNDER VACUUM AND MUST NOT BE VENTED. MULTIPLE INOCULATIONS INTO A BOTTLE SHOULD BE AVOIDED DUE TO THE POTENTIAL FOR AIR TO ENTER THE BOTTLE, WHICH MAY SUBSTANTIALLY DELAY DETECTION TIMES. USERS SHOULD CONSIDER USING A 23-GAUGE NEEDLE TO PREVENT DISRUPTION OF THE ANAEROBIC ENVIRONMENT, WHICH MAY OCCUR IF A LARGER GAUGE NEEDLE IS USED FOR INOCULATION. QUERIES OF THE MANUFACTURING DATA, AND THE COMPLAINT DATA DO NOT REVEAL ANY ADVERSE TREND FOR ANY ISSUE RELATED TO DELAYED OR FALSE NEGATIVE RESULTS FOR CLOSTRIDIUM SPOROGENES IN THE INST OR BPN BOTTLE. THE FOUR INST LOTS AND FOUR BPN LOTS REPORTED BY THE CUSTOMER HAD A REVIEW OF THEIR MANUFACTURING BATCH RECORDS. ALL LOTS MET THEIR RELEASE SPECIFICATIONS, AND THE INST QC DATA WAS SIMILAR TO THE DATA IN THE BOTTLE ¿S IFU TABLE 1 FOR CLOSTRIDIUM SPOROGENES. FOR THE BPN BOTTLE TYPE, CLOSTRIDIUM PERFRINGENS IS TESTED. THERE WERE NO CHANGES TO THE BOTTLE STOPPER, BOTTLE, MEDIA FORMULATION OR MANUFACTURING PROCESSES. THE BOTTLE STOPPER IS THE SAME PART NUMBER USED FOR ALL BACT/ALERT CULTURE BOTTLES. THE INVESTIGATOR RECOMMENDED THE FOLLOWING: DOCUMENT STRAIN BATCH NUMBER, AND HANDLE THE STOCK STRAIN BY PASSING THE INITIAL SUBCULTURE FROM THE LYOPHILIZED CULTURE, AT LEAST ONCE WHEN THE ANAEROBIC PLATE IS 48 HOURS OLD BEFORE USING FOR ANAEROBE SEEDED STUDIES. FOR ANAEROBIC STRAINS THE SUBCULTURE PLATE SHOULD BE AT LEAST 48 HOURS OLD BEFORE USING TO MAKE THE SEEDED STUDY INOCULUM SUSPENSION. USE 23 GAUGE TO 27 GAUGE NEEDLE FOR INOCULATING INTO THE BACT/ALERT BOTTLE TO REDUCE OXYGENATION. PUNCTURE BOTTLES IN THE CENTER TARGET OF THE STOPPER AND KEEP NEEDLE VERTICAL TO AVOID VENTING THE BOTTLE. TRY TO MAKE ONLY ONE PUNCTURE TO REDUCE OXYGENATION. ALWAYS HOLD SYRINGE WITH NEEDLE UP, AND TAP SYRINGE TO DISLODGE AIR BUBBLES, EJECT AIR BUBBLES UNTIL A DROP FORMS A TIP OF NEEDLE. MAKE SURE ANY NEEDLES ARE FIRMLY ATTACHED TO SYRINGE TO AVOID AIR LEAKING INTO SAMPLE AROUND HUB DURING INOCULATION. MIX BOTTLE BY INVERSION AFTER INOCULATION AND BEFORE LOADING ON INSTRUMENT. MIX ORGANISM SUSPENSION BEFORE INOCULATING EACH BOTTLE TO ENSURE THE ORGANISMS ARE EVENLY DISTRIBUTED BEFORE SAMPLING. USE A RACK TO HOLD THE BOTTLE TO PREVENT SHARPS INJURY, AND MAKE THE BOTTLE MORE STABLE DURING PUNCTURE (AVOIDS UNINTENTIONAL MOVEMENT THAT CAN INCREASE VENTING). DOCUMENT IF ANY SAMPLE IS ADDED WITH THE ORGANISM AND IF SO, IF IT CONTAINS ANY POSSIBLE INHIBITORS TO MICROBIAL GROWTH (E.G. ANTIMICROBIALS). THE BACT/ALERT IFN PLUS BOTTLE HAS A DIFFERENT MEDIA FORMULATION THAT IS ABLE TO BIND SOME OXYGEN THAT ENTERS DURING THE INOCULATION, BUT THE RECOMMENDATIONS ABOVE SHOULD STILL BE ADHERED TO, AND THE BOTTLE IFU SHOULD BE FOLLOWED. ADDING A 10 ML OXYGENATED SAMPLE TO THE BOTTLE CAN BE INHIBITORY, CONSIDER USING A SMALLER VOLUME SAMPLE IN EACH BOTTLE. CONSIDER USING A PRE-REDUCED BROTH IN ALIQUOTS, SUCH AS SCHAEDLER¿S BROTH. ADDING A NON-NUTRITIONAL SAMPLE SUCH AS WATER OR SALINE INTO THE BOTTLE, THE SAMPLE VOLUME MAY NEED TO BE LESS THAN 10 ML TO IMPROVE RECOVERY AND TIME TO DETECTION. WHEN DESIGNING THE DILUTION SCHEME, USING A LARGER INOCULUM OF ORGANISM SUSPENSION REDUCES SAMPLE ERRORS ( 1 ML VERSUS 100 UL). AVOID UNLOADING BOTTLES WHILE THEY ARE UNDER TEST. THE BOTTLE HISTORIES SHOW SOME BOTTLES WERE MOVED MULTIPLE TIMES WHILE UNDER TEST. USE THE CLINICAL BOTTLE SEEDED STUDY PROCEDURE AS A REFERENCE FOR ANAEROBES, SEE 5056 PROTOCOL - SEEDED BLOOD CULTURE STUDY - BACTALERT MICROBIAL DETECTION SYSTEM EVALUATION PROTOCOL - 60-00799-3 - CSN 5056. THE INVESTIGATION DID NOT FIND THAT THE BACT/ALERT INST CULTURE BOTTLE WAS THE ROOT CAUSE FOR THE COMPLAINT ISSUE. THERE WAS NO EVIDENCE THE INST OR BPN CULTURE BOTTLES MALFUNCTIONED. SINCE THE BACT/ALERT IFN PLUS (PART NUMBER 412990) PERFORMED BETTER WITH THE CUSTOMER¿S TEST METHOD, THEY DECIDED TO SWITCH TO USING THIS BOTTLE TYPE.

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 OF THE ISSUE: A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF OBTAINING FALSE NEGATIVE RESULTS AFTER SPIKING THE BPN BOTTLES (REFERENCE 279045, LOT#0001056109- EXPIRATION DATE: 14/08/2021) FOR GROWTH PROMOTION TESTING PERFORMED TO VALIDATE A NEW CELLULAR PRODUCT. THE CUSTOMER INDICATED THAT THE TESTS HAVE BEEN PERFORMED WITH BACTEROIDES FRAGILIS, PROPIONIBACTERIUM ACNES (DSMZ 1897), CLOSTRIDIUM SPOROGENES (ATCC® 19404¿) ON TWO LOTS : #0001056791 AND #0001056109 . BOTH LOTS ARE CONCERNED BY GROWTH ISSUES : COMPLAINT (B)(4) HAS BEEN RECORDED FOR THE LOT#0001056791. COMPLAINT (B)(4) HAS BEEN RECORDED FOR THE LOT#0001056109 (COMPLAINT CONCERNED WITH THIS ASSESSMENT). THE CUSTOMER STATED NO DEVIATION OR ISSUES ON THEIR PROCEDURE AS THE PROCEDURE WERE ALREADY VALIDATED FOR SUCH STRAINS. MOREOVER, NO ISSUES HAVE BEEN DETECTED ON THE INSTRUMENTS BY THE FIELD SERVICE ENGINEER. AS IT CONCERNS A VALIDATION TEST, NO PATIENT IMPACT HAS BEEN REPORTED. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
993903	BACT/ALERT BPN EU - 279045	BACT/ALERT BPN EU - 279045	MZC	BIOMERIEUX INC.		0001056109

Patients

Seq	Age	Sex	Outcome	Treatment
1