BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BACT/ALERT® FA PLUS CULTURE BOTTLE

    MDR report key: 7773943 · Received August 10, 2018

    Report

    Report Number
    3002769706-2018-00141
    Event Type
    Malfunction
    Date Received
    August 10, 2018
    Report Date
    January 4, 2019
    Manufacturer
    BIOMERIEUX INC.
    Product Code
    MDB
    UDI-DI
    03573026357900
    PMA / PMN Number
    K121461
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    AN INTERNAL BIOMÉRIEUX INVESTIGATION WAS PERFORMED WITH RESULTS AS FOLLOWS: ON 18JUL2018, BIOMERIEUX REQUESTED THE ISOLATE BE SENT TO DURHAM FOR TESTING. ON (B)(6) 2018, THE CUSTOMER AGREED TO SEND THE ISOLATES. ON 02AUG2018, GLOBAL CUSTOMER SERVICE (GCS) EVALUATED B.50 BTA 3D BACKUP THAT WAS MADE ON 19JUL2018. GCS EXTRACTED BOTTLE HISTORIES AND READINGS FOR THE TWO BOTTLE IDS FROM THE FALSE NEGATIVE GRAPHS SENT BY CUSTOMER: ARR6GLQJ LOADED ON 6JUL2018, ARR6GLRF LOADED ON 9JUL2018. GCS RE-RAN THE BOTTLE READINGS WITH THE GCS ALGOTOOL, AND BOTH BOTTLES FLAGGED FINAL NEGATIVE AT NINE (9) DAYS. FEEDBACK FROM BIOMATH IS AS FOLLOWS: ALGOTOOL DID NOT FLAG THE 2 BOTTLES POSITIVE. THE CURVES LOOKED POSITIVE VISUALLY, BUT THE GROWTH WAS TOO SLOW OVER TIME TO TRIGGER DETECTION. ON 15AUG2018 THE STRAINS ARRIVED AT BIOMÉRIEUX FOR TESTING. ON 22JUN2018, REVIEW OF THE MANUFACTURING DIRECTIONS (MD) WAS CONDUCTED BY THE INVESTIGATOR AT THE (B)(4), NC FACILITY. THE REVIEW ENCOMPASSED AN EVALUATION OF THE FILLING LOT BACT/ALERT® FA PLUS 4050053, LABELING AND PACKAGING (FINISHED PRODUCT FA PLUS LOT: 4050055) 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® FA PLUS LOT: 4050053 IN ACCORDANCE WITH RELEASE C METHODS. THE RESULTS MET THE SPECIFICATIONS. FINISHED GOODS BACT/ALERT® FA PLUS BOTTLE, PART NUMBER: (P/N) 410851, LOT NUMBER: 4050055 MET ALL RELEASE CRITERIA, WAS REVIEWED BY QUALITY ASSURANCE (QA) AND 7642 CASES WERE RELEASED FOR DISTRIBUTION TO THE FIELD ON 02FEB2018. INSTRUCTIONS FOR USE (IFU) REVIEW: BACT/ALERT® FA PLUS IFU, 9312050 E - 2016-04 WAS REVIEWED BY THE INVESTIGATOR ON 02JUL2018. SPECIMEN COLLECTION AND PREPARATION: GENERAL CONSIDERATIONS: 4. BIOMÉRIEUX RECOMMENDS THAT INOCULATED CULTURE BOTTLES BE PLACED INTO THE BACT/ALERT MICROBIAL DETECTION SYSTEM AS SOON AS POSSIBLE AFTER COLLECTION. IF THERE IS AN UNAVOIDABLE DELAY, INOCULATED BOTTLES MAY BE MAINTAINED AT ROOM TEMPERATURE UP TO 24 HOURS BEFORE LOADING INTO THE INSTRUMENT. PROCEDURAL NOTES AND PRECAUTIONS: 3. 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. 5. 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 EXCEED10 ML; MONITOR THE VOLUME COLLECTED BY MEANS OF THE 5 ML INCREMENTAL MARKINGS ON THE BOTTLE LABEL. LABORATORY PROCEDURE: 1. VISUALLY INSPECT BOTTLES BEFORE TESTING. DO NOT USE BOTTLES WITH EVIDENCE OF DAMAGE, LEAKAGE, OR DETERIORATION. CONSIDER BOTTLES WITH HEMOLYSIS, TURBIDITY, EXCESS GAS PRESSURE, YELLOW SENSORS, AND/OR EVIDENCE OF GROWTH AS POSITIVE. SMEAR AND SUBCULTURE. DO NOT INCUBATE UNLESS SMEAR IS NEGATIVE. 4. NEGATIVE BOTTLES MAY BE CHECKED BY SMEAR AND/OR SUBCULTURE AT SOME POINT PRIOR TO DISCARDING AS NEGATIVE. LIMITATIONS OF THE TEST: MANY VARIABLES INVOLVED IN BLOOD CULTURE TESTING CANNOT BE PRACTICALLY CONTROLLED TO PROVIDE TOTAL CONFIDENCE THAT RESULTS OBTAINED ARE DUE SOLELY TO PROPER OR IMPROPER PERFORMANCE OF ANY CULTURE MEDIUM OR DETECTION SYSTEM. PRODUCT RETURNS: NO BOTTLES WERE REQUESTED TO BE RETURNED AS A RESULT OF THIS INVESTIGATION, THE CUSTOMERS SUB-CULTURED THE INOCULATED BOTTLES. PRODUCT RETAINS: RETAIN BOTTLE VISUAL INSPECTION WAS NOT PERFORMED ON RETAIN SAMPLE SINCE THE COMPLAINT WAS NOT ABOUT VISUAL ASPECTS OF THE PRODUCT. ROOT CAUSE ANALYSIS: ON 04DEC2018, A CROSS FUNCTIONAL TEAM (CFT) COMPRISED OF GLOBAL CUSTOMER SERVICE, QUALITY ASSURANCE, INDUSTRIALIZATION AND RESEARCH AND DEVELOPMENT MICROBIOLOGY, MET TO BRAINSTORM AND DETERMINE ROOT CAUSE FOR THE FALSE NEGATIVE RESULTS. THE INFORMATION IN THE COMPLAINT AND THE GRAPHS PROVIDED BY THE CUSTOMER WERE REVIEWED AND DISCUSSED, AS WELL AS THE INFORMATION PROVIDED IN THE IFU, THE INFORMATION PROVIDED BY BIOMATH AND THE RESULTS OF THE MD REVIEW, AND TRENDING. NO TRENDS FOR FALSE NEGATIVE RESULTS FOR CANDIDA ALBICANS IN BACT/ALERT® FA PLUS BOTTLES WERE IDENTIFIED. THE REVIEW OF THE MD FOUND THE LOTS PASSED WITH NO GROWTH PERFORMANCE ISSUES. THE TEAM REVIEWED THE INFORMATION AND TROUBLESHOOTING PROVIDED IN THE COMPLAINT BY LEVEL I AND LEVEL II. THE BOTTLES WERE INOCULATED AT ONE LOCATION AND TRANSPORTED TO A DIFFERENT LOCATION PRIOR TO LOADING ON THE INSTRUMENT. THE INOCULATED BOTTLES MAY HAVE BEEN EXPOSED TO TEMPERATURES ABOVE ROOM TEMPERATURE DURING TRANSPORT FROM ONE SITE TO THE OTHER. THERE IS NO INFORMATION REGARDING EXAMINATION OF THE BOTTLE SENSOR PRIOR TO LOADING INTO THE INSTRUMENT AFTER THE DELAY BUT THE INITIAL REFLECTANCE READINGS WERE NOT HIGH ENOUGH TO CAUSE A YELLOW SENSOR; GROWTH OCCURRED AFTER LOADING, BUT WAS SLOWER THAN NORMAL. BIOMÉRIEUX DURHAM TESTED FOUR C. ALBICANS ISOLATES PROVIDED BY THE CUSTOMER UNDER FOUR CONDITIONS, NO DELAY, NO DELAY WITH THE ADDITION OF HUMAN BLOOD, EIGHT HOUR DELAY WITH THE ADDITION OF 10 ML HUMAN BLOOD AND 24 HOUR DELAY WITH THE ADDITION OF HUMAN BLOOD. THE BACT/ALERT FA PLUS BOTTLE LOT ASSOCIATED WITH EACH COMPLAINT WAS TESTED FOR EACH ISOLATE. GROWTH WAS DETECTED BY THE BACT/ALERT INSTRUMENT IN ALL CASES AND NEITHER HUMAN BLOOD NOR DELAYED ENTRY HAD A NEGATIVE IMPACT ON DETECTION. THE SLOW RATE OF REFLECTANCE CHANGE AT THE CUSTOMER SITE WAS INSUFFICIENT FOR THE ALGORITHM TO DECLARE THE BOTTLES POSITIVE. THE 100% RECOVERY AND RAPID TIMES TO DETECTION WHEN TESTED BY BIOMÉRIEUX IN DURHAM SUGGESTS THAT THE ORGANISMS WERE STRESSED, INHIBITED OR DAMAGED IN THE PATIENT'S SAMPLE. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. TREND REVIEW: THE ANALYSIS OF COMPLAINT DATA FOUND NO COMPLAINT, CAPA OR NONCONFORMANCE TRENDS RELATED TO THIS INVESTIGATION.

    Description of Event or Problem · 1

    A CUSTOMER IN (B)(6) NOTIFIED BIOMERIEUX OF FALSE NEGATIVE RESULTS ASSOCIATED WITH BACT/ALERT® FA PLUS CULTURE BOTTLE (REFERENCE 410851). THE CUSTOMER REPORTED HAVING AN AEROBIC (GREEN) BOTTLE THAT AFTER TEN (10) DAYS THE RESULT WAS NEGATIVE. THE CUSTOMER LOOKED AT THE SENSOR ON THE BOTTOM OF THE BOTTLE AND THE INDICATOR WAS YELLOW AND ALSO REVIEWED UNDER A MICROSCOPE AND IDENTIFIED YEAST. EARLIER TESTING PERFORMED ON PATIENT SAMPLE CONFIRMED THE RESULT TO BE CANDIDA ALBICANS. SUBSEQUENT TESTING WAS PERFORMED AT A LATER DATE AND THE RESULT WAS ANOTHER FALSE NEGATIVE WITH A BIOMERIEUX BACT/ALERT® FA PLUS BOTTLE. THE PATIENT WAS/IS TREATED WITH MICAMIN AND MERONEM, AND THE LABORATORY DOES NOT KNOW HOW THE PATIENT IS DOING. HE WAS ON LONG TERM CARE, GASTROINTESTINAL HEMORRHAGE, AND WOUNDS ON THE LEFT LOWER LEG. AN INTERNAL BIOMÉRIEUX INVESTIGATION WILL BE INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    613569 BACT/ALERT® FA PLUS CULTURE BOTTLE BACT/ALERT® FA PLUS CULTURE BOTTLE MDB BIOMERIEUX INC. 4050055 03573026357900

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR