BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHOENIX¿ YEAST

    MDR report key: 16642864 · Received March 30, 2023

    Report

    Report Number
    1119779-2023-00336
    Event Type
    Malfunction
    Date Received
    March 30, 2023
    Date of Event
    July 8, 2022
    Report Date
    April 24, 2023
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    JXB
    UDI-DI
    30382904483167
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    H.6 INVESTIGATION SUMMARY THIS COMPLAINT IS FOR MISIDENTIFICATION OF CANDIDA AURIS AS C. PARAPSILOSIS WHEN USING PHOENIX PANEL YEAST ID MATERIAL 448316 BATCH 1236938. THE CUSTOMER DID NOT PROVIDE PANEL RETURNS, ISOLATES OR PHOENIX GENERATED LAB REPORTS FOR THE INVESTIGATION. THE COMPLAINT BATCH WAS EXPIRED AT THE TIME OF THE INVESTIGATION AND NOT ABLE TO BE TESTED SINCE IT WAS BEYOND OUR STABILITY TIMEFRAME. AS PART OF THE INVESTIGATION, BD BRAZIL PROVIDED SAMPLES TO BD R&D FOR INVESTIGATION TESTING. THE CANDIDA AURIS STRAINS FOR WERE RECEIVED AT BD SPARKS FROM BD BRAZIL FOR TESTING BY THE BD R&D MICROBIOLOGY ID/AST GROUP. THE STRAINS WERE SUBCULTURED AND IDENTIFICATION CONFIRMATION WAS PERFORMED ON BRUKER MALDI-TOF. THE STRAINS WERE THEN SUBCULTURED ON TO SABOURAUD DEXTROSE (SAB) AGAR AND TRYPTICASE SOY AGAR PLUS 5% SHEEP¿S BLOOD (TSA+5%SB) PLATES IN PREPARATION FOR PHOENIX TESTING. ALL STRAINS WERE RUN ON YEAST ID PHOENIX PANELS MATERIAL #448316 BATCH #2123468 ON A PHOENIX M50 INSTRUMENT, AND 2 PANELS WERE PERFORMED FOR EACH STRAIN. QUALITY CONTROLS STRAINS FOR ALL TESTS WERE RUN IN PARALLEL WITH THE BD BRAZIL STRAINS. ALL STRAINS RECEIVED WERE IDENTIFIED AS C. AURIS VIA THE BRUKER MALDI-TOF. WHEN THE STRAINS WERE THEN RUN ON THE PHOENIX M50 INSTRUMENT, THE STRAINS ALL IDENTIFIED AS C. HAEMULONII/AURIS USING BOTH THE SAB DATABASE AND THE TSA+5%SB DATABASE. ALL QUALITY CONTROL RAN IN PARALLEL PASSED. THERE IS NO INDICATION THAT THE PHOENIX ID SYSTEM HAS ANY ISSUES IDENTIFYING CANDIDA AURIS STRAINS. BASED ON THE INVESTIGATION PERFORMED, THIS IS COMPLAINT IN UNABLE TO BE CONFIRMED. THE PHOENIX SYSTEM DOES NOT HAVE CLAIMS FOR SINGULAR IDENTIFICATION OF CANDIDA AURIS. INSTEAD, PHOENIX CAN PROVIDE A DUAL IDENTIFICATION OF C. HAEMULONII/AURIS. THIS DUAL IDENTIFICATION WAS ADDED TO THE PHOENIX YEAST TAXA SEVERAL YEARS AGO IN RESPONSE TO A CDC PUBLICATION THAT OUTLINED THE VARIOUS ISSUES THAT ALL PROMINENT AUTOMATED ID SYSTEMS HAVE WITH IDENTIFICATION DISCREPANCIES BETWEEN C. AURIS AND VARIOUS OTHER YEAST SPECIES. EACH ID SYSTEM HAS A TENDENCY TO MISIDENTIFY C. AURIS AS A DIFFERENT SPECIES IDENTIFICATION(S). FOR BD PHOENIX, CDC REPORTED MISIDENTIFICATIONS OF C. AURIS AS C. HAEMULONII OR C. CATENULATA. INTERNAL INVESTIGATION SUPPORTED THE INCIDENCE OF MISIDENTIFICATIONS OF C. AURIS AS C. HAEMULONII, BUT THE MISIDENTIFICATIONS AS C. CATENULATA WERE RARELY OBSERVED. BECAUSE BOTH SPECIES OF C. AURIS AND C. HAEMULONII ARE RARELY ENCOUNTERED IN THE CLINICAL LAB, A BD DECISION WAS MADE TO CHANGE THE SPECIES IDENTIFICATION OF C. HAEMULONII IN PHOENIX TO C. HAEMULONII/AURIS WITH A SPECIAL SYSTEM MESSAGE THAT WOULD EXPLAIN TO USERS THAT: ¿THE INSTRUMENT PRODUCED AN ID RESULT OF CANDIDA HAEMULONII WITH A PROFILE THAT MAY BE INDICATIVE OF CANDIDA AURIS. RECOMMEND TESTING TO RULE OUT C. AURIS.¿ A REVIEW OF QUALITY NOTIFICATIONS REVEALED NO QUALITY NOTIFICATIONS GENERATED ON THE COMPLAINT BATCH. COMPLAINT TRENDING WAS PERFORMED, AND NO TRENDS WERE IDENTIFIED ASSOCIATED WITH THIS DEFECT. THEREFORE, NO CORRECTIVE ACTIONS ARE SLATED AT THIS TIME. BD ID/AST PLANT QUALITY WILL CONTINUE TO MONITOR FOR TRENDS AND TAKE ACTION AS NECESSARY. PLEASE CONTINUE TO COMMUNICATE ANY ADDITIONAL CONCERNS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING THE BD PHOENIX¿ YEAST ID THERE WERE 3 OCCURRENCES OF MISIDENTIFICATION OF THE MICROORGANISM CANDIDA AURIS RELATED TO THE INSTRUMENT BDPHOENIX THAT WOULD HAVE IDENTIFIED THE FUNGUS AS C. PARAPSILOSIS. THE MISIDENTIFICATION WAS CONFIRMED BY GENETIC SEQUENCING. NO PATIENT IMPACT WAS REPORTED. THIS IS THE 2ND OF 2 OCCURRENCES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DESCRIPTION: MISIDENTIFICATION OF THE MICROORGANISM CANDIDA AURIS, RELATED TO THE INSTRUMENT BDPHOENIX THAT WOULD HAVE IDENTIFIED THE FUNGUS AS C. PARAPSILOSIS. THE MISIDENTIFICATION WAS CONFIRMED BY GENETIC SEQUENCING AT THE LABORATÓRIO ESPECIAL DE MICOLOGIA DA LEMI/UNIFESP/SP, WHICH IS THE REFERENCE FOR SEQUENCING CANDIDA AURIS SAMPLES/ISOLATES FROM BRAZILIAN OUTBREAKS. THE STATE OF PERNAMBUCO HAS BEEN FACING A CANDIDA AURIS OUTBREAK SINCE (B)(6) 2022. CANDIDA AURIS IS AN EMERGING FUNGUS THAT POSES A SERIOUS THREAT TO GLOBAL HEALTH BECAUSE IT CAN CAUSE INVASIVE INFECTIONS, WHICH ARE ASSOCIATED WITH HIGH MORTALITY, CAN BE MULTIRESISTANT, AND CAN LEAD TO OUTBREAKS IN HEALTHCARE FACILITIES. THE POTENTIAL MISIDENTIFICATION OF C. AURIS CASES (GENERATING FALSE NEGATIVE RESULTS AS C.PARAPSILOSIS) IS OF GREAT CONCERN, AS WELL AS THE NOISE GENERATED TO THE NATIONAL NETWORK FOR IDENTIFICATION OF CANDIDA AURIS IN HEALTH SERVICES IF IT IS NECESSARY TO INVESTIGATE ALL CASES OF C.PARAPSILOSIS ISOLATION IDENTIFIED BY THIS SYSTEM, TO AVOID POTENTIAL MISIDENTIFICATION OF C. AURIS, GIVEN THE HIGH FREQUENCY OF ISOLATION OF C. PARAPSILOSIS AS A CAUSATIVE AGENT OF CANDIDEMIA IN BRAZIL.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING THE BD PHOENIX¿ YEAST ID THERE WAS A MISIDENTIFICATION OF THE MICROORGANISM CANDIDA AURIS RELATED TO THE INSTRUMENT BDPHOENIX THAT WOULD HAVE IDENTIFIED THE FUNGUS AS C. PARAPSILOSIS. THE MISIDENTIFICATION WAS CONFIRMED BY GENETIC SEQUENCING. NO PATIENT IMPACT WAS REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DESCRIPTION: MISIDENTIFICATION OF THE MICROORGANISM CANDIDA AURIS, RELATED TO THE INSTRUMENT BDPHOENIX THAT WOULD HAVE IDENTIFIED THE FUNGUS AS C. PARAPSILOSIS. THE MISIDENTIFICATION WAS CONFIRMED BY GENETIC SEQUENCING AT THE LABORATÓRIO ESPECIAL DE MICOLOGIA DA LEMI/UNIFESP/SP, WHICH IS THE REFERENCE FOR SEQUENCING CANDIDA AURIS SAMPLES/ISOLATES FROM BRAZILIAN OUTBREAKS. THE STATE OF PERNAMBUCO HAS BEEN FACING A CANDIDA AURIS OUTBREAK SINCE (B)(6) 2022. CANDIDA AURIS IS AN EMERGING FUNGUS THAT POSES A SERIOUS THREAT TO GLOBAL HEALTH BECAUSE IT CAN CAUSE INVASIVE INFECTIONS, WHICH ARE ASSOCIATED WITH HIGH MORTALITY, CAN BE MULTIRESISTANT, AND CAN LEAD TO OUTBREAKS IN HEALTHCARE FACILITIES. THE POTENTIAL MISIDENTIFICATION OF C. AURIS CASES (GENERATING FALSE NEGATIVE RESULTS AS C.PARAPSILOSIS) IS OF GREAT CONCERN, AS WELL AS THE NOISE GENERATED TO THE NATIONAL NETWORK FOR IDENTIFICATION OF CANDIDA AURIS IN HEALTH SERVICES IF IT IS NECESSARY TO INVESTIGATE ALL CASES OF C.PARAPSILOSIS ISOLATION IDENTIFIED BY THIS SYSTEM, TO AVOID POTENTIAL MISIDENTIFICATION OF C. AURIS, GIVEN THE HIGH FREQUENCY OF ISOLATION OF C. PARAPSILOSIS AS A CAUSATIVE AGENT OF CANDIDEMIA IN BRAZIL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    591379 BD PHOENIX¿ YEAST KIT, IDENTIFICATION, YEAST JXB BECTON, DICKINSON & CO. (SPARKS) 448316 1236938 30382904483167

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown