BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BACT/ALERT® FN PLUS CULTURE BOTTLE

    MDR report key: 7792836 · Received August 17, 2018

    Report

    Report Number
    3002769706-2018-00149
    Event Type
    Malfunction
    Date Received
    August 17, 2018
    Report Date
    December 26, 2018
    Manufacturer
    BIOMERIEUX INC.
    Product Code
    MDB
    UDI-DI
    03573026357917
    PMA / PMN Number
    K121455
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE UNITED KINGDOM CUSTOMER NOTIFIED BIOMÉRIEUX, INC. OF FALSE NEGATIVE RESULTS ASSOCIATED WITH BACT/ALERT® FN PLUS BLOOD CULTURE BOTTLE (P/N) 410852, LOT 4049833 EXPIRY, DATE 10NOV18. THE CUSTOMER WAS PERFORMING RANDOM WEEKLY QUALITY CONTROL (QC) TESTING. ONE (1) PATIENT BLOOD CULTURE BOTTLE THAT FLAGGED NEGATIVE ON THE VIRTUO® INSTRUMENT WAS REMOVED FOR WEEKLY QC TESTING AS PART OF THE CUSTOMERS QC PROCESS. THE RANDOMLY SELECTED NEGATIVE BLOOD CULTURE BOTTLE WAS A BACT/ALERT® FN PLUS BLOOD CULTURE BOTTLE (P/N) 410852, LOT 4049833, EXPIRY DATE 10NOV18. A GRAM STAIN AND SUB-CULTURE WERE PERFORMED ON THE BACT/ALERT® FN PLUS BLOOD CULTURE BOTTLE, BOTTLE ID: NRJH2LQ3. THE GRAM STAINED SHOWED GRAM POSITIVE BACILLI; THE SUB-CULTURED PLATES WERE POSITIVE AND THE ORGANISM WAS IDENTIFIED BY MATRIX ASSISTED LASER DESORPTION/IONIZATION [MALDI] AS PROPIONIBACTERIUM ACNES. THE REVIEW OF THE BOTTLE IMAGE PROVIDED BY THE CUSTOMER SHOWED THE BLOOD CULTURE BOTTLE WAS OVERFILLED WITH APPROXIMATELY 20ML OF HUMAN BLOOD. GLOBAL CUSTOMER SERVICE (GCS) REVIEWED THE BOTTLE INFORMATION THAT THE LEVEL 1 SUBSIDIARY ATTACHED TO THE COMPLAINT RECORD AND LEARNED THAT THERE WAS A DELAY OF APPROXIMATELY TWENTY (20) HOURS PRIOR TO LOADING THE BOTTLE INTO THE VIRTUO® INSTRUMENT. GCS ASKED THE COLOR OF THE BOTTLE'S SENSOR, THE NUMBER OF DAYS THE BOTTLE WAS INCUBATED, IF AIR WAS INTRODUCED INTO THE BOTTLE, NEEDLE SIZE, INHIBITORY SUPPLEMENTS USED FOR BLOOD CULTURE COLLECTION, AND IF E THE ISOLATE WAS REPORTED AS CLINICALLY SIGNIFICANT OR AS A CONTAMINANT. THE CUSTOMER DID NOT PROVIDE ANSWERS. GLOBAL CUSTOMER SERVICE REQUESTED THE BACKUP FILE; THE BACKUP FILE WAS NOT PROVIDED. THE CUSTOMER PROVIDED THE NEGATIVE BOTTLE NRJH2LQ3 GRAPH FROM VIRTUO®. GCS ESCALATED THE FIVE (5) DAY GRAPH TO BIOMATH FOR REVIEW. BIOMATH VISUALLY INSPECTED THE GRAPH AND IT WAS DETERMINED THAT THE GRAPH DOES NOT LOOK LIKE A TYPICAL POSITIVE CURVE. BIOMATH RECOMMENDED OBTAINING THE BOTTLE READINGS FOR FURTHER EVALUATION. THE BOTTLE READINGS WERE UNABLE TO BE ANALYZED AS THE BACKUP WAS NOT PROVIDED. ON 26NOV18 THE CUSTOMER PROVIDED ADDITIONAL INFORMATION CONFIRMING THE BOTTLE WAS INCUBATED FOR 5 DAYS. NO CLINICAL ASSESSMENT OF THE PATIENT WAS MADE. AN AMENDED REPORT DETAILING THE ORGANISM AND PROMPTED THE USER TO CONTACT THE CONSULTANT MICROBIOLOGY IF REQUIRED. NO CONTACT WAS MADE BY THE CLINICAL TEAM MANUFACTURING DIRECTIONS (MD) REVIEW: ON 02NOV18 A REVIEW OF THE MANUFACTURING DIRECTIONS (MD) DOCUMENT (B)(4) REVISION 01.A FOR LOT 4049832 WAS CONDUCTED BY THE INVESTIGATOR AT THE (B)(6) FACILITY. THE REVIEW ENCOMPASSED AN EVALUATION OF THE FILLING LOT BACT/ALERT® FN PLUS 4049832, LABELING AND PACKAGING (FINISHED PRODUCT FN PLUS LOT 4049833) AND PROCESSES AND INSPECTIONS. THE REVIEW INCLUDED A REVIEW OF THE COMPLETE BOTTLE FORM, RACK/STACK INSPECTION FORM, AND PACKAGING DEFECT LOG. ALL INSPECTIONS MET ATTRIBUTE LIMITS. QC MICROBIOLOGY, BIOCHEMISTRY, AND ENVIRONMENTAL MONITORING (EM)/ BIOBURDEN TESTING WERE PERFORMED ON BACT/ALERT® FN PLUS LOT 4049832 IN ACCORDANCE WITH RELEASE C METHODS. GROWTH PERFORMANCE TESTING WAS PERFORMED ON EACH MEDIA BULK ON BOTTLES FROM MANUFACTURING LINE 4. THE FOLLOWING ORGANISMS WERE TESTED: BACTEROIDES FRAGILIS ATCC 25285, BACTEROIDES VULGATUS ATCC 8482, CLOSTRIDIUM PERFRINGENS ATCC 13124, ESCHERICHIA COLI 25922, STAPHYLOCOCCUS AUREUS ATCC 25923, AND STREPTOCOCCUS PNEUMONIAE ATCC 6305. B. FRAGILIS, S. AUREUS 29213, AND ENTEROCOCCUS FAECALIS ATCC 29212 WERE TESTED WITH AND WITHOUT ANTIMICROBIALS: CEFOXITIN, IMIPENEM, AND VANCOMYCIN. ALTHOUGH THE CUSTOMER'S BOTTLE WAS NOT LABELED FOR INDUSTRIAL USE, THE FILLING LOT WAS ALSO TESTED PER RELEASE C2 WITH THE FOLLOWING ORGANISMS: B. VULGATUS ATCC 8482, CLOSTRIDIUM SPOROGENES NCTC 12935, C. SPOROGENES ATCC 19434, E. COLI NCTC 12923, AND S. AUREUS NCTC 10788. THE RESULTS OF THE QC TESTING MET THE SPECIFICATIONS. FINISHED GOODS BACT/ALERT® FN PLUS BOTTLE, PART NUMBER (P/N 410852), LOT NUMBER 4049833 MET ALL RELEASE CRITERIA, WAS REVIEWED BY QUALITY ASSURANCE (QA) AND 3117 CASES WERE RELEASED FOR DISTRIBUTION TO THE FIELD ON 21DEC17. INSTRUCTIONS FOR USE (IFU) REVIEW: BACT/ALERT® FN PLUS IFU 9314507 G 2017-11 WAS REVIEWED BY THE INVESTIGATOR ON 05NOV18. THE IFU CONTAINS THE FOLLOWING INFORMATION: SPECIMEN COLLECTION AND PREPARATION. GENERAL CONSIDERATIONS: OPTIMAL RECOVERY OF ISOLATES WILL BE ACHIEVED BY ADDING MAXIMUM AMOUNTS OF SPECIMEN. USE OF LOWER VOLUMES MAY ADVERSELY AFFECT RECOVERY AND/OR DETECTION TIMES OF SOME ORGANISMS. DO NOT FILL ABOVE THE BOTTLE'S MAXIMUM SPECIMEN VOLUME OF 10 ML. THE VACUUM IN THE BOTTLE WILL USUALLY EXCEED 10 ML; MONITOR THE VOLUME COLLECTED BY MEANS OF THE 5 ML INCREMENTAL MARKINGS ON THE BOTTLE LABEL. BOTTLE PREPARATION FOR INOCULATION, USE NEEDLES WITH A GAUGE SIZE OF 21 OR HIGHER [FOR EXAMPLE 22, 23, OR 25]. USE OF NEEDLES WITH LESS THAN A 21 GAUGE SIZE [FOR EXAMPLE 16, 18, 19, OR 20] MAY VENT THE BOTTLE'S ATMOSPHERE DUE TO LARGER BORE SIZE. PROCEDURAL NOTES AND PRECAUTIONS: OBTAIN BLOOD SAMPLES PRIOR TO INITIATING ANTIBIOTIC THERAPY. IF THIS IS NOT POSSIBLE, DRAW BLOOD IMMEDIATELY BEFORE ADMINISTERING THE NEXT ANTIBIOTIC DOSE. IF INOCULATED CULTURE BOTTLES HAVE BEEN DELAYED IN THEIR RECEIPT INTO THE LABORATORY OR HAVE BEEN INCUBATED PRIOR TO ENTRY INTO THE BACT/ALERT INSTRUMENT, VISUALLY INSPECT FOR INDICATIONS OF MICROBIAL GROWTH. IF MICROBIAL GROWTH IS EVIDENT, TREAT THE BOTTLES AS POSITIVE AND DO NOT PLACE IN THE BACT/ALERT MICROBIAL DETECTION SYSTEM FOR MONITORING. LABORATORY PROCEDURE. NEGATIVE BOTTLES MAY BE CHECKED BY SMEAR AND/OR SUBCULTURE AT SOME POINT PRIOR TO DISCARDING AS NEGATIVE. LIMITATIONS OF THE TEST: IT IS POSSIBLE THAT CERTAIN RARE, FASTIDIOUS MICROORGANISMS WILL NOT GROW OR MAY GROW SLOWLY IN THE BACT/ALERT FN PLUS CULTURE BOTTLE GROWTH MEDIUM. IN ADDITION, ON RARE OCCASIONS, ORGANISMS MAY BE ENCOUNTERED THAT GROW IN THE BACT/ALERT FN PLUS CULTURE BOTTLE GROWTH MEDIUM BUT DO NOT PRODUCE SUFFICIENT CARBON DIOXIDE TO BE DETERMINED POSITIVE. IF RARE, FASTIDIOUS ORGANISMS REQUIRING SPECIALIZED MEDIA AND CULTURE CONDITIONS ARE SUSPECTED, ALTERNATIVE METHODS OR EXTENDED INCUBATION TIME SHOULD BE CONSIDERED FOR RECOVERY. THE BACT/ALERT® FN PLUS IFU CONTAINS SUFFICIENT INFORMATION REGARDING THE PROPER HANDLING OF THE BOTTLES FOR RECOVERY OF AN ANAEROBIC ORGANISM AND INTERPRETATION OF A NEGATIVE RESULT. ROOT CAUSE: BASED ON THE REVIEW OF THE BOTTLE IMAGE PROVIDED BY THE CUSTOMER, THE BOTTLE WAS OVERFILLED. THE BACT/ALERT® FN PLUS INSTRUCTIONS FOR USE STATES NOT TO FILL ABOVE THE BOTTLE'S MAXIMUM SPECIMEN. VOLUME OF 10 ML. REFER TO THE TWO REFERENCES IN THE BOTTLE IFU; CUMITECH 1C BLOOD CULTURES IV AND CLSI DOCUMENT M47-A PRINCIPLES AND PROCEDURES FOR BLOOD CULTURES, FOR INFORMATION REGARDING THE BLOOD TO BROTH RATIO. ON 15NOV18, A CROSS FUNCTIONAL TEAM (CFT) COMPRISED OF GLOBAL CUSTOMER SERVICE, QUALITY ASSURANCE, TECHNICAL SERVICES AND RESEARCH AND DEVELOPMENT MICROBIOLOGY, MET TO BRAINSTORM AND DETERMINE ROOT CAUSE FOR A P. ACNES FALSE NEGATIVE RESULT. THE TEAM REVIEWED THE COMPLAINT INFORMATION, RESULTS OF THE MD REVIEW, COMPLAINT TRENDING AND THE INFORMATION PROVIDED IN THE IFU. THERE WERE NO MANUFACTURING NONCONFORMITIES THAT COULD CONTRIBUTE TO THE FALSE NEGATIVE. THE ROOT CAUSE COULD NOT BE DETERMINED; HOWEVER, THE FOLLOWING ITEMS MAY BE CONTRIBUTING FACTORS: P. ACNES IS A SLOW GROWING ORGANISM GENERALLY REQUIRING MORE THAN FIVE (5) DAYS OF INCUBATION. ADDITIONALLY, GROWTH RATES OF P. ACNES ARE VERY STRAIN DEPENDENT. IT IS UNKNOWN IF THE PATIENT WAS ON ANTIMICROBIAL THERAPY WHICH COULD HINDER RECOVERY. THE BOTTLE WAS OVERFILLED WHICH COULD BE A CONTRIBUTING FACTOR. IT IS UNKNOWN IF THE BOTTLE WAS INADVERTENTLY VENTED DURING INOCULATION. PRODUCT RETURNS: PRODUCT RETURNS WERE NOT REQUESTED AS THE BOTTLES WERE DISCARDED BY THE CUSTOMER. PRODUCT RETAINS: INSPECTION OF THE RETAIN SAMPLES BACT/ALERT® BOTTLES WAS NOT PERFORMED AS THE COMPLAINT WAS NOT FOR A VISUAL ASPECT OF THE BOTTLE.

    Description of Event or Problem · 1

    A CUSTOMER IN THE (B)(6) NOTIFIED BIOMÉRIEUX OF FALSE NEGATIVE RESULTS ASSOCIATED WITH BACT/ALERT® FN PLUS CULTURE BOTTLE (REFERENCE (B)(4)). THE CUSTOMER REPORTED DURING WEEKLY QUALITY CONTROL TESTING, ONE OF THE BLOOD CULTURE BOTTLES WAS FLAGGED NEGATIVE ON THE VIRTUO® INSTRUMENT. THE NEGATIVE BOTTLE GREW PROPIONIBACTERIUM ACNES. THERE IS NO PATIENT ASSOCIATED WITH THE TEST, THIS IS A QUALITY CONTROL SAMPLE. AN INTERNAL BIOMÉRIEUX INVESTIGATION WILL BE INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    633690 BACT/ALERT® FN PLUS CULTURE BOTTLE BACT/ALERT® FN PLUS CULTURE BOTTLE MDB BIOMERIEUX INC. 4049833 03573026357917

    Patients

    Seq Age Sex Outcome Treatment
    1