BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BACT/ALERT FA PLUS (PLASTIC) ®

    MDR report key: 19526676 · Received June 13, 2024

    Report

    Report Number
    3002769706-2024-00023
    Event Type
    Malfunction
    Date Received
    June 13, 2024
    Report Date
    August 27, 2024
    Manufacturer
    BIOMERIEUX INC.
    Product Code
    MDB
    UDI-DI
    03573026357900
    PMA / PMN Number
    K121461
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONTEXT: THE COMPLAINT WAS RECEIVED FOR TWO (2) BACT/ALERT FA PLUS CULTURE BOTTLE LOTS IN WHICH THE CUSTOMER OBTAINED A FALSE POSITIVE RESULT FOR TEN (10) BOTTLES FROM LOT 0004102422 (EXPIRY DATE 19FEB2025) AND ONE (1) BOTTLE FROM LOT 0004102464 (EXPIRY DATE 06MAR2025) FOR E. CLOACAE COMPLEX WITH EPLEX BCID TESTING. THREE (3) OF THE BOTTLES (ONE (1) FROM LOT 0004102422 AND TWO (2) FROM LOT 0004102464 ALSO HAD A FALSE POSITIVE BCID RESULT FOR SERRATIA/S. MARCESCENS. GRAM STAIN AND SUBCULTURE RESULTS DID NOT CONFIRM THESE ORGANISMS WERE PRESENT IN THE FA PLUS BOTTLES. THE CUSTOMER PROVIDED BOTTLE IDENTIFICATIONS (IDS) FOR EIGHT (8) OUT OF TEN (10) FA PLUS BOTTLES FROM LOT 0004102422 AND THE ONLY FA PLUS BOTTLE FROM LOT 0004102464. 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** A TOTAL OF ELEVEN (11) PATIENT RESULTS WITH POSITIVE BACT/ALERT® FA PLUS BOTTLES RELATING TO FALSE POSITIVE BCID RESULTS FOR ENTEROBACTER CLOACAE (E. CLOACAE) COMPLEX WITH GENMARK DX® EPLEX® BLOOD CULTURE IDENTIFICATION (BCID) PANEL. TEN (10) BOTTLES WERE FROM LOT 0004102422 (EXPIRY DATE 19FEB2025) AND ONE (1) BOTTLE WAS FROM LOT 0004102464 (EXPIRY DATE 06MAR2025). THREE (3) OF THE BOTTLES (ONE (1) FROM LOT 0004102422 AND TWO (2) FROM LOT 0004102464) HAD FALSE POSITIVE BCID RESULTS FOR SERRATIA/SERRATIA MARCESCENS WITH THE EPLEX BCID PANEL. NO HARM TO PATIENTS WAS REPORTED FOR THE COMPLAINTS ASSOCIATED WITH THIS INVESTIGATION. THE INSTRUCTIONS FOR USE FOR THE EPLEX BLOOD CULTURE IDENTIFICATION (BCID) PANEL USED FOR TESTING PROVIDED ADEQUATE DIRECTIONS FOR REDUCING POTENTIAL CONTAMINATION DURING THE TESTING PROCESS. PRODUCTS (E.G., BACT/ALERT BOTTLES, MOLECULAR PANELS) WERE USED IN CONJUNCTION WITH OTHER DIAGNOSTIC TEST RESULTS FOR THE TREATMENT OF THE PATIENTS. MATERIALS AND ENVIRONMENT. MATERIALS: THE CUSTOMER TESTED ELEVEN (11) DIFFERENT PATIENTS WITH TEN (10) FA PLUS CULTURE BOTTLES FROM LOT 0004102422 (EXPIRY DATE 19FEB2025) AND ONE (1) FA PLUS CULTURE BOTTLE FROM LOT 0004102464 (EXPIRY DATE 06MAR2025). ALL BOTTLES WERE DETERMINED TO HAVE ¿DETECTION¿ OF ENTEROBACTER CLOACAE COMPLEX (E. CLOACAE COMPLEX) WITH EPLEX BCID MOLECULAR TEST PANEL. THREE (3) OF THE BOTTLES FROM FA PLUS LOT 0004102422 ALSO WERE DETERMINED TO HAVE ¿DETECTION¿ OF SERRATIA AND/OR SERRATIA MARCESCENS. SAMPLES FROM THE POSITIVE BOTTLES WERE TESTED WITH GRAM STAIN AND SUBCULTURE. ALL GRAM STAINS RESULTED WITH GRAM NEGATIVE RODS (GNR). ALL SUBCULTURES GREW ORGANISMS IDENTIFYING WITH GNR (E.G., CITROBACTER FREUNDII, ESCHERICHIA COLI, ETC.). E. CLOACAE COMPLEX AND SERRATIA AND/OR SERRATIA MARCESCENS (ALSO GNR) DID NOT GROW IN THE ANY OF THE SUBCULTURES; THEREFORE, CONTRIBUTING TO THE FALSE POSITIVE BCID RESULTS. BACT/ALERT CULTURE BOTTLES: RAW MATERIALS FOR BACT/ALERT PRODUCT IS A CONTRIBUTING SOURCE FOR NON-VIABLE NUCLEIC ACIDS. THE BLOOD CULTURE BOTTLES CONTAIN MEDIA COMPONENTS THAT ORIGINATE FROM ANIMAL/PLANT WHERE NON-VIABLE NUCLEIC ACIDS (E.G., SERRATIA MARCESCENS) WILL BE EVIDENT AS A RESULT OF PROCESSING THESE RAW MATERIALS. THIS WILL NOT IMPACT THE FUNCTIONALITY OF THE BACT/ALERT CULTURE BOTTLE; IT IS PART OF THE BOTTLE DESIGN. BIOFIRE BCID2 MOLECULAR (INCLUDES E. CLOACAE COMPLEX AND SERRATIA MARCESCENS ON THE PANEL) TESTING OF RAW MATERIALS IS PART OF INCOMING INSPECTIONS REQUIREMENTS. HOWEVER, DISTRIBUTION OF NON-VIABLE NUCLEIC ACIDS WITHIN THE RAW MATERIAL LOTS IS AN UNKNOWN. FA PLUS QUALITY CONTROL (QC) TESTING WITH BIOFIRE BCID2 PANEL. ALL BACT/ALERT CULTURE BOTTLE LOTS REQUIRE MOLECULAR TESTING OF ALL MEDIA BULKS WITHIN THE LOT BY USING THE BIOFIRE® BLOOD CULTURE IDENTIFICATION 2 (BCID2) PANEL. THE BIOFIRE BCID2 MOLECULAR TEST PANEL INCLUDES E. CLOACAE COMPLEX AND SERRATIA MARCESCENS. BACT/ALERT FA PLUS CULTURE BOTTLES, AS PER A SAMPLING PLAN DESCRIBED IN THE RELEASE PROCEDURE, ARE SUBMITTED TO THE QUALITY CONTROL (QC) LABORATORY FOR BCID2 TESTING. THIS TESTING PROVIDES DETECTION OF NON-VIABLE NUCLEIC ACIDS IN BACT/ALERT PRODUCT. THE CUSTOMER PROVIDED BOTTLE IDENTIFICATIONS (IDS) FOR EIGHT (8) OUT OF TEN (10) FA PLUS BOTTLES FROM LOT 0004102422 AND THE ONLY FA PLUS BOTTLE FROM LOT 0004102464. INDUSTRIALIZATION AT THE DURHAM MANUFACTURING SITE WAS ABLE TO TRACE THE BOTTLES TO THE BULK LOT THESE SUSPECT BOTTLES ORIGINATED FROM (E.G., BOTTLES FROM LOT 0004102422 WERE FROM THE FIFTH BULK AND THE BOTTLE FROM LOT 0004102464 WAS FROM THE FOURTH BULK). MELT ANALYSIS DATA FOR THE BCID RESULTS WERE EVALUATED AND CONFIRMED THERE WAS ¿NO DETECTION¿ FOR ENTEROBACTER CLOACAE COMPLEX OR SERRATIA MARCESCENS WITHIN EITHER OF THE FA PLUS LOTS. IN ADDITION, THE CUSTOMER TESTED TWO (2) UNINOCULATED FA PLUS BOTTLES FROM LOT 0004102422 WITH THE EPLEX BCID MOLECULAR TEST PANEL AND NO ORGANISMS WERE DETECTED. THE CUSTOMER DID NOT IDENTIFY THE EPLEX PANEL TYPE; HOWEVER, E. CLOACAE COMPLEX AND SERRATIA/SERRATIA MARCESCENS ARE PART OF THE GENMARK EPLEX® BLOOD CULTURE IDENTIFICATION (BCID) GRAM- NEGATIVE PANEL (BCID-GN) PANEL: ENTEROBACTER CLOACAE COMPLEX, ENTEROBACTER ASBURIAE, ENTEROBACTER HORMAECHEI, AND ENTEROBACTER LUDWIGII. THESE ORGANISMS ARE KNOWN TO BE ASSOCIATED WITH A HOSPITAL/CLINICAL ENVIRONMENT. ARTICLE: ENTEROBACTER CLOACAE COMPLEX: CLINICAL IMPACT AND EMERGING ANTIBIOTIC RESISTANCE; M.L. MEZZATESTA, F. GONA, AND S. STEFANI; ARTICLE IN FUTURE MICROBIOLOGY-JULY 2012; DOI: 10.2217/FMB.12.61.SOURCE: PUBMED. THE FOLLOWING INFORMATION RELATES TO THIS INVESTIGATION: ENTEROBACTER CLOACAE HAS BEEN KNOWN TO CONTAMINATE MEDICAL EQUIPMENT (E.G., INTRAVENOUS) AND BEEN ASSOCIATED WITH NOSOCOMIAL (ORIGINATING IN THE HOSPITAL SETTING) OUTBREAKS RELATED TO SURGICAL EQUIPMENT, OPERATIVE CLEANING SOLUTIONS, HEPARIN SOLUTION USED TO IRRIGATE CERTAIN INTRAVASCULAR DEVICES ENTERBACTER ASBURIAE HAS BEEN KNOWN ISOLATED FROM SOIL, PLANTS, AND HUMAN SOURCES ENTERBACTER HORMAECHEI IS COMMONLY ISOLATED IN HOSPITALS WITH CLINICAL SIGNIFICANCE ENTERBACTER LUDWIGII WAS FIRST ISOLATED IN A URINE SAMPLE OF A PATIENT AND HAS BEEN ASSOCIATED WITH SEWAGE WATER IN A HOSPITAL ENVIRONMENT AS PER THE IFU FOR THE EPLEX BCID-GN TEST PANEL, SERRATIA IS PART OF THE ENTEROBACTERALES FAMILY. IT HAS EMERGED AS A CLINICALLY SIGNIFICANT PATHOGEN. SOURCES OF INFECTION/CONTAMINATION INCLUDE VARIOUS MODES OF TRANSMISSION (E.G., LIQUID SOAP DISPENSERS, SALINE SOLUTIONS, TAP WATER, VARIETY OF MEDICAL DEVICES, ANTISEPTICS); HOWEVER, THE MOST COMMON MODE OF TRANSMISSION IS BY HANDS OF HOSPITAL EMPLOYEES. SERRATIA MARCESCENS IS THE MOST COMMON SPECIES OF SERRATIA AND CAN BE FOUND IN BATHROOMS AROUND SOURCES OF WATER. THE CUSTOMER REPEATED THE SAMPLING OF EIGHT (8) POSITIVE FA PLUS BOTTLES (SEVEN (7) FROM LOT 0004102422 AND THE ONE (1) BOTTLE FROM LOT 0004102464) WITH THE EPLEX BCID MOLECULAR TEST PANEL. REPEAT RESULTS SHOWED FOUR (4) OUT OF THE SEVEN (7) BOTTLES WERE DETERMINED THE HAVE ¿DETECTION¿ OF E. CLOACAE COMPLEX AND ONE (1) BOTTLE WAS DETERMINED TO HAVE ¿DETECTION¿ FOR SERRATIA/SERRATIA MARCESCENS. IN ADDITION, ONE (1) OUT OF THE FOUR (4) BOTTLES WAS DETERMINED TO HAVE ¿DETECTION¿ FOR SERRATIA WHICH WAS ONLY DETECTED UPON REPEAT TESTING. REPEAT EPLEX RESULTS OF SEVERAL POSITIVE FA PLUS BOTTLES WERE INCONSISTENT WITH THE ¿DETECTION¿ OF E. CLOACAE COMPLEX AND SERRATIA. MATERIALS ARE A CONTRIBUTING FACTOR TO THIS COMPLAINT. ENVIRONMENT: ENVIRONMENTAL CONDITIONS SUCH AS DUST, DIRT, LIGHT, TEMPERATURE, BIOLOGICAL MATERIAL, AND HUMIDITY CONDITIONS ARE CONTRIBUTING FACTORS TO CONTAMINATION OF A PATIENT¿S SAMPLE, IF THE SAMPLE BECAME EXPOSED TO ONE OR MORE OF THESE CONDITIONS. THE CUSTOMER OFFERS A WIDE VARIETY OF TESTS FOR CLINICAL PATIENT SAMPLES. PATIENT SAMPLES ARE RECEIVED FROM DIFFERENT CLINICAL LOCATIONS (E.G., DOCTOR¿S OFFICES, MEDICAL CLINICS, HOSPITALS). THE CUSTOMER DID NOT REPORT ANY CONTAMINATION ISSUE WITHIN THEIR FACILITY FOR E. CLOACAE COMPLEX OR S. MARCESCENS; HOWEVER, THE PRESENCE OF THESE ORGANISMS CAN EXIST ON FREQUENTLY TOUCHED SURFACES. ARTICLE: BACTERIAL SURVIVAL ON INANIMATE SURFACES: A FIELD STUDY; R. H. KATZENBERGER, A. ROSEL, AND R.P. VONBERG. KATZENBERGER ET AL. BMC RES NOTES (2021) 14:97; HTTPS://DOI.ORG/10.1186/S13104-021-05492-0. THE FOLLOWING INFORMATION RELATES TO THIS INVESTIGATION: FREQUENTLY TOUCHED SURFACES ARE A FACTOR IN THE NOSOCOMIAL (ORIGINATING IN A HOSPITAL SETTING) SPREAD OF MICROBIAL ORGANISMS. E. CLOACAE AND S. MARCESCENS WERE PART OF THE PANEL OF STRAINS USED FOR THIS STUDY. HOSPITAL SURFACES TESTED WERE GLASS (E.G., TABLET PCS, CELL PHONES, OTHER TOUCH SCREENS), POLYVINYL CHLORIDE (E.G., LIGHT SWITCHES, SHELVES, CUPBOARDS, BATHROOMS, BED RAILS, ALARM BUTTONS), STAINLESS STEEL (E.G., DOORKNOBS, PREPARATION AREAS FOR INTRAVENOUS INFUSIONS), ALUMINUM (E.G., HANDRAILS, ELEVATOR BUTTONS). SURFACES WERE DECONTAMINATED PRIOR TO ADDITION OF BACTERIA SAMPLES. ROOM TEMPERATURE WAS AT 21°C AND AT RELATIVE HUMIDITY (31 TO 35%) TO MIMIC ROUTINE CARE UNITS FOR PATIENTS. CONTACT PLATES WERE USED TO SAMPLE SURFACES AT INCREMENTAL DAYS FROM 1 TO 28 AND WERE INCUBATED AT 37°C OVERNIGHT. ALL NOSOCOMIAL ORGANISMS MAY SURVIVE AT LEAST A FEW DAYS AND CAN POSE A RISK OF TRANSMISSION THROUGH A HOSPITAL SETTING. GRAPHS PLOTTING THE ORGANISM TYPE VERSE THE NUMBER OF SURVIVAL DAYS SHOWED THE FOLLOWING RESULTS FOR SERRATIA MARCESCENS AND ENTEROBACTER CLOACAE: GLASS SURFACES (E.G., CELL PHONES, TOUCH SCREENS): BOTH SURVIVED ~7 DAYS. STAINLESS STEEL SURFACES (E.G., LIGHT SWITCHES): BOTH SURVIVED ~2 DAYS. POLYVINYL CHLORIDE SURFACES (E.G., DOORKNOBS): BOTH SURVIVED ~7 DAYS. ALUMINUM SURFACES (ELEVATOR BUTTONS): BOTH SURVIVED ~4 DAYS. SERRATIA MARCESCENS (¿SMA¿ IN TABLE 1) WAS ALSO FOUND TO SURVIVE ON SURFACES UNDER DIFFERENT ENVIRONMENTAL CONDITIONS: TAP WATER: =12 DAYS AT ROOM TEMPERATURE, 7 DAYS AT 30°C AND 2 DAYS AT 40°C COTTON, POLYESTER AND POLYETHYLENE: 1-2 HOURS (10^2 CFU), AND 12 HOURS TO 10 DAYS (10^4 TO 10^5 CFU). IT WAS UNKNOWN IF ONE LABORATORY ANALYST TESTED ALL THE POSITIVE BOTTLES FOR BCID AT THE SAME TIME (¿BATCH TESTED¿) IN THE AREA DESIGNATED FOR THIS TESTING OR DIFFERENT LABORATORY ANALYST PERFORMED THE BCID TESTING OF THE PATIENT SAMPLES AT DIFFERENT TIMES. THE TIMES TO DETECTION (TTD) FOR SIX (6) POSITIVE BOTTLES THAT THE CUSTOMER WAS ABLE TO PROVIDE WERE UNDER 14 HOURS. BATCH TESTING WOULD LEND ITSELF TO A POTENTIAL EXPOSURE OF THE SAME ORGANISM (E.G., E. CLOACAE COMPLEX) PRESENT IN THE ENVIRONMENT TO ALL SAMPLES TESTED AT THE SAME TIME. REPEAT BCID TESTING OF SEVEN (7) BOTTLES SHOWED FOUR (4) OF THE BOTTLES STILL HAD THE PRESENCE OF E. CLOACAE COMPLEX, SUGGESTING THE ORGANISM WAS STILL ON A SURFACE OR MATERIAL USED IN THE TESTING ENVIRONMENT. SAMPLES FROM POSITIVE BLOOD CULTURE BOTTLES SHOULD BE LOADED INTO THE CARTRIDGES IN A ¿AMPLICON-FREE, CLEAN ENVIRONMENT¿ (E.G., BIOSAFETY CABINET) AS PER THE IFU. ALL LABORATORY AREAS AND AFFECTED EQUIPMENT SHOULD BE DECONTAMINATED WITH APPROPRIATE AGENTS (E.G., 10% BLEACH FOLLOWED BY 70% ETHANOL OR ISOPROPYL ALCOHOL OR EQUIVALENT). POTENTIAL CONTAMINATION TO CARTRIDGES CAN OCCUR DURING PROCESSING AND THUS CONTAMINATE THE BAYS AFTER INSERTION. IN TURN, FUTURE CARTRIDGES CAN BE CONTAMINATED. APPROPRIATE DISINFECTANT SHOULD BE USED TO CLEAN THE BAYS AND CLEAN THE EPLEX INSTRUMENT MODULE AS PER THE EPLEX INSTRUMENT MANUAL. AFTER DECONTAMINATION, A CHECK SHOULD BE PERFORMED WITH A KNOWN NEGATIVE CONTROL TO CONFIRM THE BAYS OF THE EPLEX INSTRUMENT ARE NOT CONTAMINATED AND READY TO USE FOR ¿AMPLICON-FREE¿ (NO REMNANTS OF NUCLEIC ACIDS) TESTING. ORGANISMS CAN BE FOUND ON SURFACES TOUCHED EVERYDAY BY PERSONNEL (E.G., CELL PHONES, LIGHT SWITCHES) AND CAN REMAIN ON SURFACES FOR SEVERAL DAYS (E.G., DOORKNOBS, LAB COATS). THE PRESENCE OF THESE ORGANISM CAN ALSO SURVIVE IN DIFFERENT ENVIRONMENTAL CONDITIONS (E.G., WATER) AND CAN BE TRANSPORTED FROM ONE LOCATION TO ANOTHER WITH THE DELIVERY OF PATIENT SAMPLES TO THE LABORATORY. USE OF PROPER DISINFECTANTS ON ROUTINELY USED SURFACES DESIGNATED FOR TESTING PATIENT SAMPLES AND CLEANING DEVICES (E.G., CELL PHONES, CARTRIDGE BAYS ON EPLEX INSTRUMENT), HAND WASHING BY STAFF, CHANGING GLOVES OFTEN, CAN REDUCE THE PRESENCE OF ORGANISMS SURVIVING FOR PERIODS OF TIME ON FREQUENTLY TOUCHED SURFACES. ENVIRONMENT IS A POTENTIAL CONTRIBUTING FACTOR TO THIS COMPLAINT. RETURNED PRODUCTS AND TESTING: RETURNED BOTTLES FROM THE FINISHED FA PLUS LOTS WERE NOT REQUIRED FOR DETERMINING ROOT CAUSE FOR THIS INVESTIGATION. CONCLUDE PRODUCT COMPLIANCE TO SPECIFICATION/PERFORMANCE. THERE IS NO EVIDENCE OF ANY BOTTLE MALFUNCTION WITH THE BACT/ALERT FA PLUS CULTURE BOTTLE LOTS. THE BACT/ALERT BOTTLES DETECTED ORGANISM GROWTH AS INTENDED. BCID TESTING IS BEING CONDUCTED ON DESIGNATED RAW MATERIALS AND SAMPLES REPRESENTING ALL MEDIA BULKS FOR THE FILL LOTS FOR BACT/ALERT PRODUCTS. TESTING OF ALL THE MEDIA BULKS THAT CONTRIBUTE TO THE FILL LOT FILLS WILL AID IN MONITORING PRODUCT CONTAINING NUCLEIC ACID RESIDUAL IN AN EFFORT TO REDUCE THE CHANCES OF CUSTOMERS OBTAINING FALSE POSITIVE RESULTS WITH BCID PANEL TESTING.

    Description of Event or Problem · 0

    INTENDED U BACT/ALERT® FA PLUS CULTURE BOTTLES ARE USED WITH BACT/ALERT® MICROBIAL DETECTION SYSTEMS IN QUALITATIVE PROCEDURES FOR RECOVERY AND DETECTION OF AEROBIC AND FACULTATIVE ANAEROBIC (BACTERIA AND YEAST) FROM BLOOD AND OTHER NORMALLY STERILE BODY FLUIDS. DESCRIPTION OF THE ISSUE A CUSTOMER IN THE UNITED STATES NOTIFIED BIOMÉRIEUX OF EIGHT (8) FALSE POSITIVE DETECTIONS OF ENTEROBACTER CLOACAE WITH ROCHE GENMARK EPLEX BCID PANEL WHEN TESTING BLOOD SAMPLES INOCULATED IN BACT/ALERT FA PLUS (PLASTIC) - 410851 (LOT# 0004102422, EXPIRATION DATE. 2/19/2025 ). ONE (1) ADDITIONAL COMPLAINT (B)(4) WAS OPENED TO DOCUMENT THE SAME ISSUE OCCURRING WITH A DIFFERENT FA PLUS LOT NUMBER (LOT# 0004102464, EXPIRATION DATE 6-MAR-2025) WITH ONE PATIENT SAMPLE. CUSTOMER REPORTED THAT WHILE USING THE FA PLUS BOTTLES (LOT# 0004102422 & LOT# 0004102464) AND THE EPLEX BCID PANEL (LOTS 10200649 AND 10205573), ORGANISMS WERE IDENTIFIED. FOR TWO (2) OF THE PATIENTS, THE ROCHE BCID MOLECULAR RESULT WAS REPORTED TO THE DOCTOR. THE CUSTOMER INDICATED THAT THEY NOTIFIED ROCHE OF THE ISSUE; IT IS UNKNOWN IF THEIR COMPLAINT WAS DETERMINED TO BE REPORTABLE TO THE FDA. NOTE : TWO UNINOCULATED BACT/ALERT FA PLUS BOTTLES (LOT UNKNOWN) WERE TESTED FOR STERILITY AND RESULTED "NEGATIVE". **SUMMARY** RESULTS - PATIENT 1 - SAMPLE ID : (B)(6) ROCHE BCID DETECTED : CITROBACTER, E. CLOACAE COMPLEX, PROTEUS MIRABILIS CULTURE GREW: C. FREUNDII, P. MIRABILIS REPEAT BCID: CITROBACTER, E. CLOACAE COMPLEX, PROTEUS MIRABILIS PLUS BOTTLE TYPE & LOT #: AEROBIC (FA) 4102422. RESULTS - PATIENT 2 - SAMPLE ID : (B)(6) ROCHE BCID DETECTED : E. CLOACAE COMPLEX, E. COLI CULTURE GREW: E. COLI REPEAT BCID: E. CLOACAE COMPLEX, E. COLI PLUS BOTTLE TYPE & LOT #: AEROBIC (FA) 4102422. RESULTS - PATIENT 3 - SAMPLE ID : (B)(6) ROCHE BCID DETECTED : E. CLOACAE COMPLEX, E. COLI CULTURE GREW: E. COLI REPEAT BCID: E. COLI PLUS BOTTLE TYPE & LOT #: AEROBIC (FA) 4102422. RESULTS - PATIENT 4 - SAMPLE ID : (B)(6) ROCHE BCID DETECTED : E. CLOACAE COMPLEX, K. PNEUMONIAE GROUP CULTURE GREW: KPNE REPEAT BCID: E. CLOACAE COMPLEX, K. PNEUMONIAE GROUP, SERRATIA PLUS BOTTLE TYPE & LOT #: AEROBIC (FA) 4102422. RESULTS - PATIENT 5 - SAMPLE ID : (B)(6) ROCHE BCID DETECTED : E. CLOACAE COMPLEX, E. COLI, K. PNEUMONIAE GROUP CULTURE GREW: E. COLI, KPNE REPEAT BCID: E. COLI, K. PNEUMONIAE GROUP PLUS BOTTLE TYPE & LOT #: AEROBIC (FA) 4102422. RESULTS - PATIENT 6 - SAMPLE ID : (B)(6) ROCHE BCID DETECTED : E. CLOACAE COMPLEX, SALMONELLA CULTURE GREW: SALM SP, REPEAT BCID: SALMONELLA PLUS BOTTLE TYPE & LOT #: AEROBIC (FA) 4102422. RESULTS - PATIENT 7 - SAMPLE ID : (B)(6) ROCHE BCID DETECTED : E. CLOACAE COMPLEX, E. COLI, SERRATIA & SERRATIA MARCESCENS CULTURE GREW: E. COLI REPEAT BCID: E. CLOACAE COMPLEX, E. COLI, SERRATIA & SERRATIA MARCESCENS PLUS BOTTLE TYPE & LOT #: AEROBIC (FA) 4102422. RESULTS - PATIENT 8 - SAMPLE ID : (B)(6) ROCHE BCID DETECTED : E. CLOACAE COMPLEX, E. COLI CULTURE GREW: E. COLI REPEAT BCID: E. COLI PLUS BOTTLE TYPE & LOT #: AEROBIC (FA) 4102464. RESULTS - PATIENT 9 - SAMPLE ID : (B)(6) ROCHE BCID DETECTED : E. CLOACAE COMPLEX, SALMONELLA CULTURE GREW: SALM SP REPEAT BCID: NOT PERFORMED PLUS BOTTLE TYPE & LOT #: AERO (FA) 4102422. THERE IS NO INDICATION OR REPORT FROM THE CUSTOMER THAT THIS EVENT 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
    780091 BACT/ALERT FA PLUS (PLASTIC) ® BACT/ALERT FA PLUS (PLASTIC) ® MDB BIOMERIEUX INC. 410851 0004102422 03573026357900

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown