BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BACT/ALERT® FA PLUS BOTTLE

    MDR report key: 7926601 · Received October 2, 2018

    Report

    Report Number
    3002769706-2018-00192
    Event Type
    Malfunction
    Date Received
    October 2, 2018
    Report Date
    January 7, 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 07SEP18 THE CUSTOMER REPORTED ANOTHER BLOOD CULTURE FALSE NEGATIVE FOR C. ALBICANS AFTER 5.6 DAYS. THE PATIENT WAS ALREADY UNDER TREATMENT AS A PREVIOUS SAMPLE WAS POSITIVE FOR STAPHYLOCOCCUS SPECIES AND YEAST BUT STAPHYLOCOCCUS WAS LATER RULED OUT. THE SENSOR OF THE BACT/ALERT® FA PLUS LOT 4050629 BOTTLE APPEARED TO BE YELLOW. THE PATIENT WITH PANCREATITIS WAS BEING TREATED WITH PIPERACILLIN/ TAZOBACTAM AT THE TIME OF SAMPLING. THE CUSTOMER CONFIRMED THE PATIENT WAS NOT ON AN ANTIFUNGAL. THE GRAPHS WERE SENT AND THE BACKUP REQUESTED. ON 18SEP18, ADDITIONAL INFORMATION WAS PROVIDED. THE AEROBIC BOTTLE FLAGGED POSITIVE TWO (2) DAYS AFTER THE BOTTLES HAD BEEN INSERTED INTO THE BACT/ALERT INSTRUMENT. THE FALSE NEGATIVE BOTTLE WAS OVERFILLED WITH 10 ML EXTRA BLOOD. ON 19SEPT18 THE COMPLAINT WAS DISCUSSED DURING THE CROSS FUNCTIONAL TEAM MEETING (CFT) AND ADDITIONAL QUESTIONS WERE SENT TO THE CUSTOMER. 24SEPT18 THE CUSTOMER STATED THAT THEY DID NOT SEE A PATTERN WITH A NOSOCOMIAL INFECTION. 03OCT18 THE PAPERWORK WAS SENT FOR THE RETURN OF THE ISOLATE. 30OCT18 THE ISOLATES WERE RECEIVED FROM THE CUSTOMER. 03DEC18 A REVIEW OF THE BACT/ALERT® 3D BACKUP WAS PERFORMED. THE FAULT CODES/ ERROR CODES WERE NOT CONTRIBUTING FACTORS TO THE FALSE NEGATIVE BOTTLE ISSUE. BIOMATH REVIEWED THE DATA AND DETERMINED BASED ON THE ALGOTOOL OUTPUT, THE ALGORITHM DETECTED A SLOW GROWTH BUT THE GROWTH IS TOO SLOW TO REACH THE DETECTION THRESHOLD SET FOR BACT/ALERT® FA PLUS BOTTLE. ON 16OCT18, REVIEW OF THE MANUFACTURING DIRECTIONS (MD) WAS CONDUCTED BY THE INVESTIGATOR AT THE DURHAM, NC FACILITY. THE REVIEW ENCOMPASSED AN EVALUATION OF THE FILLING LOT BACT/ALERT® FA PLUS 4050629, LABELING AND PACKAGING (FINISHED PRODUCT BACT/ALERT® FA PLUS LOT 4050629) 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 4050629 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 4050629 MET ALL RELEASE CRITERIA, WAS REVIEWED BY QUALITY ASSURANCE (QA), AND 4130 CASES WERE RELEASED FOR DISTRIBUTION TO THE FIELD ON 01JUN18. INSTRUCTIONS FOR USE (IFU) REVIEW BACT/ALERT® FA PLUS IFU, 9312050 E - 2016-04 WAS REVIEWED BY THE INVESTIGATOR ON 02JUL18. SPECIMEN COLLECTION AND PREPARATION: GENERAL CONSIDERATIONS: 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: 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. 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 10ML; MONITOR THE VOLUME COLLECTED BY MEANS OF THE 5 ML INCREMENTAL MARKINGS ON THE BOTTLE LABEL. LABORATORY PROCEDURE: 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. 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 04DEC18, 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. 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 BOTTLE (REFERENCE 410851). THE CUSTOMER REPORTED OBTAINING A FALSE NEGATIVE RESULT FOR CANDIDA ALBICANS. WHEN THE CUSTOMER EXAMINED THE SENSOR ON THE BOTTOM OF THE BOTTLE IT WAS YELLOW, AND YEAST HAD GROWN. SO THE CUSTOMER DECIDED TO SUBCULTURE IT. THE CUSTOMER REPORTED THAT THE PATIENT WAS ALREADY RECEIVING MEDICAL TREATMENT (ANTIFUNGAL TREATMENT) DUE TO A PREVIOUS SAMPLE THAT WAS POSITIVE FOR "STAPH" AND YEAST. AFTER FURTHER EXAMINATION "STAPH" WAS RULED OUT. PATIENT HAS PANCREATITIS AND WAS TREATED WITH PIPERACILLIN/ TAZOBACTAM AT THE TIME OF COLLECTING THE BLOOD SAMPLE. THERE WAS NO DELAY IN REPORTING CORRECT RESULTS TO THE PHYSICIAN BECAUSE, A SUBSEQUENT BOTTLE WAS FLAGGED POSITIVE TWO (2) DAYS AFTER THE FALSE NEGATIVE BOTTLE WAS INSERTED INTO THE INSTRUMENT. AN INTERNAL BIOMÉRIEUX INVESTIGATION WILL BE INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    766917 BACT/ALERT® FA PLUS BOTTLE BACT/ALERT® FA PLUS BOTTLE MDB BIOMERIEUX INC. 4050629 03573026357900

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR