BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITEK MS INSTRUMENT

    MDR report key: 11673925 · Received April 15, 2021

    Report

    Report Number
    9615754-2021-00069
    Event Type
    Malfunction
    Date Received
    April 15, 2021
    Report Date
    June 8, 2021
    Manufacturer
    BIOMÉRIEUX, SA
    Product Code
    QBN
    UDI-DI
    03573026359119
    PMA / PMN Number
    K181412
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT DOCUMENTS A MISIDENTIFICATION OF ISOLATE 5 AS CITROBACTER FREUNDII WHEN CULTURED ON CARBA WITH MAST ESBK/KPC-AGAR. THE OTHER FOUR (4) MISIDENTIFICATION EVENTS WILL BE REPORTED IN SEPARATE REPORTS. INVESTIGATION THE INVESTIGATOR REVIEWED THE COMPLAINTS DATABASE FOR PREVIOUS REPORTS SIMILAR TO THIS CUSTOMER'S ISSUE. NO OTHER COMPLAINT HAS BEEN RECORDED REGARDING MISIDENTIFICATION OF CITROBACTER BRAAKII AS C. FREUNDII. ADDITIONALLY, NO CAPAS NOR NON-CONFORMITIES WERE FOUND LINKED WITH CUSTOMER'S COMPLAINT. FINE TUNING THE FINE TUNING ANALYZER REPORT INDICATED THAT NO FINE TUNING WAS NEEDED DURING THE CUSTOMER¿S TESTS. FINE TUNING APPEARED GOOD. SPOT PREPARATION THE CALIBRATOR AND SAMPLE ¿ALL PEAKS¿ VALUES ARE HETEROGENEOUS. THIS SUGGESTS A NON-OPTIMAL SPOT PREPARATION OF THE CALIBRATOR STRAIN (CULTURE, SPOT, DIFFERENT OPERATOR, OPERATOR SKILLS, ¿). THE SAMPLE ¿ALL PEAKS¿ ARE HOMOGENEOUS. KNOWLEDGE BASE REVIEW BASED ON CUSTOMER INFORMATION, THE ORGANISM IS BELIEVED TO BE C. BRAAKII (WHICH IS PRESENT IN THE VITEK® MS KNOWLEDGE BASE V3.2), BUT THE CUSTOMER DID NOT USE ANY REFERENCE METHOD TO CONFIRM THIS IDENTIFICATION. SAMPLE DATA ANALYSIS BASED ON THE RAW DATA PROVIDED, THE SAMPLE ¿ALL PEAKS¿ VALUES ARE QUITE HOMOGENEOUS, THE SAMPLE SPOT PREPARATION SEEMS TO BE GOOD. SEVERAL CULTURE MEDIA WERE USED TO TEST BOTH SAMPLES AND THE POTENTIAL MISIDENTIFICATION WAS OBSERVED WITH ALL OF THEM FOR SAMPLE 113816 AND ONLY WITH BLOOD AGAR FOR SAMPLE 1082001. TWO OF THE MEDIA TYPES, ESBL WITH MAST ESBK/KPC-AGAR AND CARBA WITH MAST ESBK/KPC-AGAR, HAVE NOT BEEN VALIDATED AS COMPATIBLE WITH VITEK® MS. HOWEVER, THE POTENTIAL ISSUE ALSO OCCURRED WITH VALIDATED CULTURE MEDIA (BLOOD AGAR AND MACCONKEY AGAR), THUS THE ISSUE CANNOT BE LINKED TO THE CULTURE MEDIA TYPE USED. MOST OF THE IDENTIFICATIONS WERE IDENTIFIED WITH A LOW SCORE AND MANY OF THEM ARE NEAR THE LIMIT VALUE OF -0.4 FOR GIVING A 'NO IDENTIFICATION' RESULT. THE CUSTOMER DID NOT INDICATE HOW HE OBTAINED THE 'EXPECTED' IDENTIFICATION; SEQUENCING OF THE STRAIN IS NEEDED TO CONFIRM THE STRAINS IDENTIFICATION. HEREAFTER THE INFORMATION REGARDING THE TAXONOMY OF CITROBACTER AND R&D DEPARTMENT¿S COMMENTS : ¿AS CITROBACTER SPECIES ARE NOW WELL DIFFERENTIATED, WE NO LONGER REFERENCE ¿COMPLEX¿; HOWEVER, THAT DOES NOT PREVENT THESE SPECIES FROM REMAINING CLOSE. THE FDA HAD ASKED US TO ADD THIS NOTE IN THE VITEK MS KB USER MANUAL TO WARN CUSTOMERS THAT THESE SPECIES BEING CLOSE, IT IS POSSIBLE TO HAVE CROSS IDENTIFICATION OR LOW DISCRIMINATIONS BETWEEN THEM AND THAT THE RESULT SHOULD BE CONSIDERED TO BE CITROBACTER FREUDII COMPLEX.¿ IN THE VITEK MS KB V3.2 USER MANUAL THERE IS AN ¿ADDITIONAL NOTE¿ THAT STATES "CITROBACTER FREUNDII, CITROBACTER BRAAKII AND CITROBACTER YOUNGAE SHOULD BE CONSIDERED AS CITROBACTER FREUNDII COMPLEX¿. ON 30 APR 2021, THE INVESTIGATION TEAM REQUESTED THE CUSTOMER SUBMIT THE STRAINS IN QUESTION FOR FURTHER INVESTIGATION. ON 21 MAY 2021, IT WAS DISCLOSED THAT THE CUSTOMER STRAINS WERE NO LONGER AVAILABLE. ROOT CAUSE UNKNOWN. CORRECTIVE AND PREVENTATIVE ACTIONS ROOT CAUSE COULD NOT BE DETERMINED. LOCAL CUSTOMER SERVICE PROVIDED ADDITIONAL TRAINING MATERIALS TO THE CUSTOMER REGARDING SPOT PREPARATION TECHNIQUE. SERVICE ALSO PROVIDED INFORMATION REGARDING VITEK® PICKMETM (REF (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER FROM (B)(6) REPORTED THAT HE OBTAINED MISIDENTIFICATIONS OF C. BRAAKII AS C. FREUNDII WHEN USING VITEK MS INSTRUMENT (REF. 410895) ¿ SERIAL NUMBER: (B)(4). THE CUSTOMER REPORTED THAT TO CONFIRM THE IDENTIFICATION OF TWO CITROBACTER BRAAKII SAMPLES, THE STRAINS WERE TESTED FROM SEVERAL MEDIA ON VITEK MS AND THE FOLLOWING RESULTS WERE OBTAINED: BLOOD AGAR: SAMPLE 1: SINGLE CHOICE TO C. FREUNDII 99,9%. SAMPLE 2: SINGLE CHOICE TO C. FREUNDII 99,9%. MACCONKEY: SAMPLE 1: LOW DISCRIMINATION C. FREUNDII 50%, C. BRAAKII50%. THIS LOW DISCRIMINATION IS NOT CONSIDERED AS A MISIDENTIFICATION AS THE EXPECTED RESULT (C. BRAAKII) IS SUGGESTED IN THIS LOW DISCRIMINATION. SAMPLE 2: SINGLE CHOICE TO C. FREUNDII 99,9%. ESBL WITH MAST ESBK/KPC-AGAR: SAMPLE 1: LOW DISCRIMINATION C. FREUNDII 50%, C. BRAAKII 50%. THIS LOW DISCRIMINATION IS NOT CONSIDERED AS A MISIDENTIFICATION AS THE EXPECTED RESULT (C. BRAAKII) IS SUGGESTED IN THIS LOW DISCRIMINATION. SAMPLE 2: SINGLE CHOICE TO C. FREUNDII 99,9%. CARBA WITH MAST ESBK/KPC-AGAR: SAMPLE 1: SINGLE CHOICE TO C. BRAAKII 99,9% AS EXPECTED. SAMPLE 2: SINGLE CHOICE TO C. FREUNDII 99,9%. THIS REPORT DOCUMENTS A MISIDENTIFICATION OF ISOLATE 2 AS CITROBACTER FREUNDII WHEN CULTURED ON CARBA WITH MAST ESBK/KPC-AGAR. THE OTHER FOUR (4) MISIDENTIFICATION EVENTS WILL BE REPORTED IN SEPARATE REPORTS. VITEK MS SHOULD BE ABLE TO IDENTIFY C. BRAAKII AND C. FREUNDII AS A SINGLE CHOICE. HOWEVER, IN THE VITEK MS KNOWLEDGE BASE V3.2 USER MANUAL THERE IS AN ADDITIONAL NOTE SAYING THAT: "CITROBACTER FREUNDII, CITROBACTER BRAAKII AND CITROBACTER YOUNGAE SHOULD BE CONSIDERED AS CITROBACTER FREUNDII COMPLEX." THIS NOTE WAS ADDED TO WARN CUSTOMERS THAT THESE SPECIES BEING CLOSE, IT IS POSSIBLE TO HAVE CROSS IDENTIFICATION OR LOW DISCRIMINATIONS BETWEEN THEM AND THAT THE RESULT SHOULD BE CONSIDERED TO BE CITROBACTER FREUDII COMPLEX.. THERE IS NO INDICATION FROM THE CUSTOMER IF THIS ISSUE IMPACTED THE PATIENT STATE OF HEALTH OR LED TO A DELAY OF RESULTS. A BIOMÉRIEUX INTERNAL INVESTIGATION HAS BEEN INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    570620 VITEK MS INSTRUMENT VITEK® MS INSTRUMENT QBN BIOMÉRIEUX, SA 410895 03573026359119

    Patients

    Seq Age Sex Outcome Treatment
    1