BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BACT/ALERT FA PLUS (PLASTIC)

    MDR report key: 12599796 · Received October 8, 2021

    Report

    Report Number
    3002769706-2021-00050
    Event Type
    Malfunction
    Date Received
    October 8, 2021
    Report Date
    May 6, 2022
    Manufacturer
    BIOMERIEUX INC.
    Product Code
    MDB
    UDI-DI
    03573026357900
    PMA / PMN Number
    K121461
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN INTERNAL INVESTIGATION WAS PERFORMED IN RESPONSE TO A NOTIFICATION FROM A CUSTOMER IN THE UNITED STATES THAT THEY OBTAINED A FALSE NEGATIVE RESULT WITH ONE FA PLUS CULTURE BOTTLE ON THEIR BACT/ALERT® 3D VERSION B.50 INSTRUMENT WITH SERIAL NUMBER (B)(6). THE INITIAL BOTTLE WAS SUBCULTURED AND THE ORGANISM IDENTIFIED WAS CANDIDA PARAPSILOSIS. THE CUSTOMER STATED THE FALSE NEGATIVE RESULT WAS FOR ONE (1) BOTTLE OUT OF FOUR (4) BOTTLES FOR THE SAME PATIENT. HOWEVER, THEY NOTED THAT THE SENSOR ON THE BOTTOM OF THE BOTTLE WAS YELLOW; INDICATING A POSITIVE RESULT. THE OTHER THREE (3) BACT/ALERT CULTURE BOTTLES (UNKNOWN LOT NUMBERS) WERE POSITIVE AND ALSO IDENTIFIED THE ORGANISM CANDIDA PARAPSILOSIS. THE CUSTOMER COLLECTED TWO BOTTLE SETS (SET IS ONE AEROBIC BOTTLE AND ONE ANAEROBIC BOTTLE) OF BLOOD CULTURES (FOUR BOTTLES). AS PER M47-A-CLSI: PRINCIPLES AND PROCEDURES FOR BLOOD CULTURES; APPROVED GUIDELINE; CLSI DOCUMENT M47-A. WAYNE, PA: CLINICAL AND LABORATORY STANDARDS INSTITUTE; 940 WEST VALLEY ROAD, SUITE 1400 WAYNE, PENNSYLVANIA 19087-1898 USA;2007.COPYRIGHT ©2007: ¿THE PRESENT GUIDELINE IS TO COLLECT TWO TO THREE SETS PER EPISODE. SINGLE BLOOD CULTURES SHOULD NEVER BE DRAWN FROM ADULT PATIENTS; THIS PRACTICE RESULTS IN AN INADEQUATE VOLUME OF BLOOD CULTURED, AND THE RESULTS OF SINGLE BLOOD CULTURES ARE MORE DIFFICULT TO INTERPRET.¿ THE MORE SETS OF BLOOD CULTURES DRAWN FROM AN ADULT PATIENT (E.G. 3 SETS) INCREASES THE YIELD OF ORGANISMS FOR A POSITIVE DETECTION. THE PATIENT WAS ON ANTIBIOTIC TREATMENT (NOT IDENTIFIED BY CUSTOMER) AND KNOWN TO HAVE A HISTORY OF A YEAST INFECTION. THE CUSTOMER CONFIRMED THE FA PLUS FALSE NEGATIVE BOTTLE WAS HELD AT ROOM TEMPERATURE UNTIL LOADED INTO THE INSTRUMENT APPROXIMATELY 1 ½ HOURS AFTER SAMPLE COLLECTION WHICH WAS NOT A DELAYED ENTRY AS PER INSTRUCTION FOR USE (IFU).THE CUSTOMER TESTED THE CULTURE BOTTLES ON A BACT/ALERT 3D INSTRUMENT; HOWEVER, A BACKUP OF DATA WAS NOT PROVIDED BY THE CUSTOMER. INVESTIGATION RETAIN SAMPLE TESTING: THE CUSTOMER DID NOT PROVIDE THE CLINICAL STRAIN INVOLVED IN THIS INCIDENT. AS A RESULT, BIOMÉRIEUX R&D USED STRAINS THAT WERE ALREADY IN-HOUSE ALONG WITH RETAINED BOTTLES FROM THE LOT IN QUESTION. A GROWTH PERFORMANCE EVALUATION OF CANDIDA PARAPSILOSIS WAS CONDUCTED USING TWO (2) CLINICAL ISOLATES AND ONE (1) COMMERCIALLY AVAILABLE STRAIN AT DIFFERENT INOCULUM CONCENTRATIONS (=100 CFU/BOTTLE) WITH TWO (2) DIFFERENT FA PLUS LOT NUMBERS (INCLUDING LOT 0004100010). THIS TESTING INVOLVED A MATRIX OF COMPONENTS TO SHOW THE GROWTH PERFORMANCE OF CANDIDA PARAPSILOSIS IN BACT/ALERT FA PLUS CULTURE BOTTLES. COMPONENTS ARE HIGHLIGHTED BELOW: ¿ TWO DIFFERENT FA PLUS CULTURE BOTTLE LOTS (0004100010, EXPIRY 30OCT2021, AND 0004100436, EXPIRY 21AUG2022) ¿ TWO CLINICAL ISOLATES (WUMC-006, WUMC-008) AND ONE ATCC® 22019¿ STRAIN. ¿ EACH CULTURE BOTTLE WAS INOCULATED WITH 4ML OF DONOR BLOOD WITHOUT ANTIBIOTICS AND 0.35% SODIUM POLYANETHOLSULFONATE (SPS, ANTICOAGULANT). ¿ TWO INOCULUM CONCENTRATIONS = 50CFU/BOTTLE. ¿ INCUBATION OF INOCULATED CULTURE BOTTLES FOR 5 DAYS AT 35°C +/- 1°C (CLINICAL SET POINT). ¿ AFTER THE BOTTLES WERE INOCULATED, PLATE COUNTS WERE PREPARED TO CONFIRM PURITY OF CULTURES. ALL FA PLUS CULTURE BOTTLES MET THE ACCEPTANCE CRITERIA OF 100% RECOVERY OF CANDIDA PARAPSILOSIS IN LESS THAN FIVE (5) DAYS (120 HOURS) WITH THE MAXIMUM TIME TO DETECTION (TTD) OBSERVED AS 47.8 HOURS. THE CULTURE BOTTLES WERE SEEDED WITH TWO INOCULUM CONCENTRATIONS THAT RANGED BETWEEN 10-14 CFU/BOTTLE AND 38-50 CFU/BOTTLE. THE FASTER TTD FOR EACH CULTURE BOTTLE WAS ASSOCIATED WITH A HIGHER INOCULUM CONCENTRATION. THE TEST RESULTS OF THE TWO CLINICAL ISOLATES AND THE ONE ATCC STRAIN OF CANDIDA PARAPSILOSIS IN THIS STUDY WERE COMPARED TO THE TEST RESULTS OBTAINED DURING THE NEW MEDIA VERSION (NMV) OF FA PLUS. THE COMPARISON OF THE TTD FOR THE COMPLAINT DATA SHOWED SIMILAR GROWTH PERFORMANCE TO THE HISTORICAL NMV DATA. THE OVERALL EVALUATION CONCLUDES THAT THE FA PLUS LOT 0004100010 PERFORMED AS PER DESIGN AND THE ROOT CAUSE OF FALSE NEGATIVE RESULTS OBTAINED BY THE CUSTOMER CANNOT BE ATTRIBUTED TO BACT/ALERT CULTURE BOTTLES. LITERATURE: THE INVESTIGATOR REVIEWED A PUBLISHED STUDY PERTAINING TO CANDIDA PARAPSILOSIS IN RELATION TO BLOODSTREAM INFECTIONS THAT WAS CONDUCTED OVER A FIVE YEAR PERIOD AT A HOSPITAL LOCATED IN ITALY: FACTORS RELATED TO OUTCOME OF BLOODSTREAM INFECTIONS DUE TO CANDIDA PARAPSILOSIS COMPLEX: BARCHIESI ET AL. BMC INFECTIOUS DISEASES (2016) 16:387 DOI 10.1186/S 12879-016-1704-Y. THE STUDY INDICATED THAT CANDIDA PARAPSILOSIS TAKES A LONGER TIME TO REACH A POSITIVE RESULT IN BLOOD CULTURES THAN OTHER CANDIDA SPECIES (E.G. C. ALBICANS AND C. TROPICALIS). THE GROWTH OF THIS YEAST-LIKE FUNGAL PATHOGEN COULD BE DELAYED IN PRELIMINARY BLOOD CULTURE SAMPLES AND THUS ANTIFUNGAL TREATMENT WOULD BE ADEQUATE AFTER THIS INITIAL TIME PERIOD OF TESTING. THIS CANDIDA SPECIES POSSESS A NATURAL LOW SUSCEPTIBILITY TO ANTIFUNGAL DRUGS THAT TARGET FUNGAL CELL WALLS (ECHINOCANDINS). THE INOCULATED VOLUME BY THE CUSTOMER IN THE FA PLUS CULTURE BOTTLE IS UNKNOWN. FILLING THE CULTURE BOTTLE UNDER OR OVER THE RECOMMENDED 10ML CAN AFFECT THE REFLECTANCE READINGS. THE IFU FOR FA PLUS AND THE REFERENCE TO CUMITECH 1C BLOOD CULTURES IV, ASM PRESS, 2005. ON : PAGE 26, UNDER SPECIMEN COLLECTION, IT STATES: ¿THE PERCENTAGE OF BLOOD SAMPLES >2 ML OVER OR BELOW THE RECOMMENDED VOLUME FOR THE VIAL TYPE SHOULD BE DETERMINED AND APPROPRIATE IN-SERVICE ACTIVITIES PRESENTED TO THOSE PHLEBOTOMY GROUPS WITH PROBLEMS. FALSE-NEGATIVE RESULTS CAN BE ATTRIBUTED TO BOTH TOO LITTLE BLOOD AND TOO MUCH BLOOD, WHICH MAY ALLOW CLOTTING AND TRAPPING OF ORGANISMS INSIDE THE CLOT.¿ SAMPLE SOURCE: THE CUSTOMER STATED THAT THE PATIENT SAMPLE WAS A BLOOD SAMPLE DRAWN FROM THE CENTRAL LINE. THE FA PLUS IFU RECOMMENDS THE DRAWING OF BLOOD SAMPLES PRIOR TO INITIATING ANTIBIOTIC THERAPY. IF THIS IS NOT POSSIBLE, DRAW BLOOD IMMEDIATELY BEFORE ADMINISTERING THE NEXT ANTIBIOTIC DOSE. IN ADDITION, THE IFU INDICATES THAT THE BACT/ALERT FA PLUS CULTURE BOTTLE HAS THE CAPABILITY TO NEUTRALIZE ANTIMICROBIALS BY THE PRESENCE OF ADSORBENT POLYMERIC BEADS. ACTUAL NEUTRALIZATION IN A FA PLUS CULTURE BOTTLE VARIES DEPENDING UPON DOSAGE LEVEL OF ANTIBIOTICS AND TIMING OF SPECIMEN COLLECTION. THE CUSTOMER COULD NOT CONFIRM IF PERSONNEL INSPECTED THE FALSE NEGATIVE FA PLUS CULTURE BOTTLE PRIOR TO LOADING ONTO THE 3D INSTRUMENT. THE ARYW4LWJ BOTTLE GRAPH DID NOT INDICATE PRESENCE OF AN ORGANISM BEFORE USE, AS THE REFLECTANCE OF ABOUT 3200 AT LOADING WAS NOT OVERLY HIGH (INDICATING IT WAS CONTAMINATED BEFORE USE). FURTHER, IT IS UNKNOWN IF THE CUSTOMER LOADED THE FALSE NEGATIVE FA PLUS CULTURE BOTTLE PROPERLY BY INSERTING THE BOTTLE ALL THE WAY INTO THE INSTRUMENT CELL. AN ERRONEOUS TEST RESULT (E.G. FALSE NEGATIVE) COULD OCCUR IF A BOTTLE IS NOT FULLY SEATED INTO A CELL. THE BACT/ALERT 3D MIGHT ALARM IF THIS ISSUE OCCURS WITH A RACK ERROR (51/99, 52/99, 53/99) AS DESCRIBED IN THE BACT/ALERT 3D USER MANUAL 514818-1EN1 (PAGE 12-10). CUSTOMER DID NOT PROVIDE A 3D BACKUP FOR EVALUATION, SO INSTRUMENT ERRORS COULD NOT BE CONFIRMED. DEVICE HISTORY RECORD AND COMPLAINT ANALYSIS: QUERIES OF MANUFACTURING DATA FOR THE BACT/ALERT FA PLUS CULTURE BOTTLE LOT 0004100010 (EXPIRY DATE 30OCT2021) DID NOT REVEAL ANY ANOMALIES OR NON-CONFORMANCES. QUERIES ON COMPLAINT DATA DID NOT SHOW ANY SYSTEMIC QUALITY ISSUE. THERE IS NO EVIDENCE OF ANY BOTTLE MALFUNCTION WITH THE BACT/ALERT FA PLUS CULTURE BOTTLE LOTS. MONITORING AND DETECTION METHODS FOR BOTTLE DEFECTS ASSOCIATED WITH POTENTIAL FALSE NEGATIVE RESULTS ARE PART OF THE MANUFACTURING AND QUALITY CONTROL PROCESSES FOR BACT/ALERT CULTURE BOTTLES. THE INVESTIGATOR REVIEWED THE INSTRUCTIONS FOR USE [IFU] AND BACT/ALERT 3D USER MANUAL AND DETERMINED IT PROVIDES ADEQUATE DIRECTIONS TO REDUCE THE CHANCES OF OBTAINING FALSE NEGATIVE RESULTS WITH BACT/ALERT BOTTLES: ¿ VENIPUNCTURE IS THE TECHNIQUE OF CHOICE FOR OBTAINING BLOOD CULTURES. ¿ OBTAIN BLOOD SAMPLES PRIOR TO INITIATING ANTIBIOTIC THERAPY. IF THIS IS NOT POSSIBLE, DRAW BLOOD IMMEDIATELY BEFORE ADMINISTERING THE NEXT ANTIBIOTIC DOSE. ¿ DO NOT FILL THE BACT/ALERT CULTURE BOTTLES OVER (>2ML) OR UNDER (<2ML) THE RECOMMENDED VOLUME IN THE INSTRUCTIONS FOR USE FOR BOTTLE TYPE. ¿ MAINTAIN AMBIENT ROOM TEMPERATURE FOR CULTURE BOTTLE STORAGE AND BACT/ALERT INSTRUMENT OPERATIONS. ¿ VISUALLY INSPECT CULTURE BOTTLE (E.G. SENSOR COLOR) PRIOR TO LOADING INTO BACT/ALERT INSTRUMENT. ¿ INSERT THE CULTURE BOTTLE FULLY SEATED INTO THE INSTRUMENT CELL.

    Description of Event or Problem · 0

    INTENDED USE: 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 PROBLEM: A CUSTOMER IN THE UNITED STATES NOTIFIED BIOMÉRIEUX OF A FALSE NEGATIVE RESULT WITH CANDIDA PARAPSILOSIS IN ASSOCIATION WITH BACT/ALERT FA PLUS (PLASTIC) (REF. 410851, BATCH NUMBER 0004100010, EXPIRATION DATE 30-OCT-2021) REGARDING A PATIENT BOTTLE. IT HAS BEEN REPORTED THAT ONE FA PLUS BOTTLE FLAGGED FINAL NEGATIVE AND WAS OBSERVED BY THE CUSTOMER AS HAVING A YELLOW BOTTLE SENSOR (INDICATING POSITIVE) UPON UNLOAD. THE CUSTOMER PERFORMED A GRAM STAIN AND SUBCULTURE ON THE BOTTLE AND THE BOTTLE'S GRAM STAIN WAS SUGGESTIVE OF YEAST WITH FURTHER SUBCULTURE THAT GREW THE YEAST ORGANISM CANDIDA PARAPSILOSIS. IT¿S UNDERSTOOD THAT THE PATIENT HAD A TOTAL OF FOUR (4) BOTTLES AND ALL BOTTLES GREW CANDIDA PARAPSILOSIS. THE INSTRUMENT DID NOT DETECT THE GROWTH OR PRESENCE OF THE ORGANISM IN THE FA PLUS BOTTLE. THE CUSTOMER STATED THERE WAS NO DELAY IN PATIENT TREATMENT SINCE OTHER BOTTLES FLAGGED POSITIVE FOR THE SAME ORGANISM. THERE IS NO INDICATION OR REPORT FROM THE LABORATORY THAT THE FALSE NEGATIVE RESULT LED TO ANY ADVERSE EVENT RELATED TO THE PATIENT'S STATE OF HEALTH. AN INVESTIGATION WILL BE INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1495927 BACT/ALERT FA PLUS (PLASTIC) BACT/ALERT FA PLUS (PLASTIC) MDB BIOMERIEUX INC. 0004100010 03573026357900

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown