BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITEK MS PRIME

    MDR report key: 15216013 · Received August 12, 2022

    Report

    Report Number
    9615754-2022-00096
    Event Type
    Malfunction
    Date Received
    August 12, 2022
    Report Date
    September 21, 2022
    Manufacturer
    BIOMÉRIEUX, SA
    Product Code
    QBN
    UDI-DI
    03573026611422
    PMA / PMN Number
    K212461
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A CUSTOMER IN PORTUGAL REPORTED TO BIOMÉRIEUX THAT THEY HAVE OBTAINED A POTENTIAL MISIDENTIFICATION OF STREPTOCOCCUS CONSTELLATUS AS E. COLI WHILE USING VITEK MS PRIME (REF. 423281, SERIAL NUMBER (B)(6)). INSTRUMENT: VITEK MS PRIME ; MODE : IVD ; KB VERSION : 3.2 (CLI) ISSUE TYPE : MISIDENTIFICATION - ESCHERICHIA COLI INSTEAD OF STREPTOCOCCUS CONSTELLATUS VITEK MS RESULTS - LAB ID (B)(6) : 25 JUL 2022 (DS220625956 SPOT B3) = SINGLE CHOICE TO ESCHERICHIA COLI 26 JUL 2022 (DS220625954 SPOT C4) = SINGLE CHOICE TO STREPTOCOCCUS CONSTELLATUS NOTES : THE FIRST IDENTIFICATION (SPOT B3) WAS MADE WITH COLONIES FROM COS. THE SECOND IDENTIFICATION (SPOT C4) WAS MADE FROM PVX (NEW CULTURE) THE PLATES THAT CUSTOMER USED FOR DOING THE IDENTIFICATIONS WERE PURE (NO MIXED CULTURE) THE SAMPLES PREPARATION WERE MADE WITH VITEK PICKME OTHER METHODS : GRAM STAINING = GRAM POSITIVE WHICH IS NOT IN FAVOR TO ESCHERICHIA COLI SUBCULTURE ON SEVERAL PLATES LIKE COS, PVX AND MCK. THERE WAS NO GROWTH IN MCK, SO THE IDENTIFICATION IS NOT IN FAVOR OF ESCHERICHIA COLI BECAUSE IT SHOULD GROW ON THIS KIND OF CULTURE MEDIA (MACCONKEY AGAR WITH CRYSTAL VIOLET IS A SELECTIVE ISOLATION AND DIFFERENTIATION MEDIUM FOR THE DETECTION OF ENTEROBACTERIA IN SPECIMENS OF VARIOUS ORIGINS). EXPECTED ID: BASED ON THE COMPLAINT DESCRIPTION IT SHOULD BE STREPTOCOCCUS CONSTELLATUS CULTURE CONDITIONS: ORIGIN : PLEURAL LIQUID CULTURE MEDIA : COS AND PVX INCUBATION: 24H TO 48H ISSUE DATE: 25 JUL 2022 FINE TUNING DATE BEFORE THE ISSUE: UNKNOWN INVESTIGATION: BATCH HISTORY RECORD AND TREND ANALYSIS THERE IS NO CAPA, NO NON-CONFORMITY ON VITEK MS PRIME LINKED WITH CUSTOMER 'S COMPLAINT. A TREND ANALYSIS HAS BEEN DONE REGARDING THE COMPLAINTS RECORDED FOR THE ERROR CODE MIS ID - SAMPLE PREPARATION ISSUE - F562 (FROM JUNE 2021 TO AUGUST 2021) ; NO TREND HAS BEEN IDENTIFIED. INVESTIGATION RESULTS FINE TUNING ACCORDING TO THE VILINK ALERT TOOL CRITERIA, A FINE TUNING WAS NEEDED DURING THE TESTS MADE ON 25 JUL 2022. THE NUMBER OF ¿ALL PEAKS¿ AND ¿GOOD PEAKS¿ HAVE FALL DOWN UNDER THE VILINK ALERT TOOL LIMIT. HOWEVER, IT HAS NOT BEEN TAKEN AS A CAUSE OF THE ISSUE IN THIS CASE, THE CALIBRATOR VALUES WERE ¿GOOD¿ DURING THE SPOTS ACQUISITION. SPOT PREPARATION QUALITY THE CALIBRATOR AND SAMPLE ¿ALL PEAKS¿ VALUES ARE QUITE HETEROGENEOUS. BASED ON THIS FINDING, THE SPOT PREPARATION QUALITY NEEDS TO BE VERIFIED WITH THE CUSTOMER. KB REVIEW STREPTOCOCCUS CONSTELLATUS ARE PRESENT IN VITEK MS KB V3.2. SAMPLE DATA ANALYSIS THE SAMPLE ALL PEAKS VALUES ARE QUITE HETEROGENEOUS, IT VARIES BETWEEN 81 AND 120. HOWEVER, THE AMOUNT OF PEAKS IN BOTH SPECTRA ARE ACCEPTABLE. THESE DIFFERENCES IN TERM OF ¿NUMBER PEAKS¿ COULD BE DUE TO THE FACT THAT THE FIRST TEST (SPOT B3) WAS MADE WITH COLONIES ISOLATED ON COS AGAR AND THAT THE SECOND TEST (SPOT C4) WAS MADE FROM COLONIES ISOLATED FROM PVX AGAR (NEW CULTURE) THE ANALYSIS OF SPOT B3 GIVING THE POTENTIAL MISIDENTIFICATION GAVE ESCHERICHIA COLI ALLOWS TO SHOW THAT THE SPOT B3 INCLUDES ALL THE PEAKS OF ESCHERICHIA COLI (5096 DA, 5381 DA, 6255 DA, 7158 DA, 7274 DA, 7872 DA, ETC) BUT ALSO INCLUDES MAJOR SPECIFICS PEAKS OF STREPTOCOCCUS CONSTELLATUS (5229 DA, 5288 DA, 5316 DA, 5853 DA, 5895 DA, 6982 DA, 7574 DA, 9472 DA, ETC). THIS ANALYSIS CONFIRM THAT THERE WAS A MIX BETWEEN THE CALIBRATOR STRAIN (E. COLI ATCC 8739) AND THE SAMPLE (SPOT B3). BY REPROCESSING THE CUSTOMER DATA WITH SARAMIS (RUO DATABASE), THE SPECTRA FROM SPOT B3 GIVING THE POTENTIAL MISIDENTIFICATION LED TO ESCHERICHIA COLI AND STREPTOCCOCUS SPECIES (INCLUDING STREPTOCOCCUS CONSTELLATUS). THIS ANALYSIS ALSO CONFIRM THAT THERE WAS A MIX BETWEEN THE CALIBRATOR STRAIN (E. COLI ATCC 8739) AND THE SAMPLE (SPOT B3) DURING SPOTS PREPARATION. FOR REMINDER, CALIBRATOR SPOT AND SPOT B3 ARE VERY CLOSED TOGETHER. THE AMOUNT OF ¿ACCEPTED PROFILES¿ VERSUS ¿REJECTED PROFILE¿ ARE CORRECT FOR BOTH SPOTS B3 AND C4. HOWEVER, THE AMOUNT OF ¿REJECTED PROFILES¿ FOR SPOT B3 (SPOT GIVING THE POTENTIAL MISIDENTIFICATION TO ESCHERICHIA COLI) IS HIGHER THAN THE REJECTED PROFILES FROM SPOT C4, IT INDICATES THAT SPOT QUALITY SEEMS TO BE BETTER WITH SPOT C4. CONCLUSION: THE MOST PROBABLE IDENTIFICATION (EXPECTED IDENTIFICATION AFTER INVESTIGATION) IS STREPTOCOCCUS CONSTELLATUS. HOWEVER, IT HAS TO BE CONFIRMED BY A REFERENCE METHOD (SEQUENCING). BASED ON THE PICTURE OF THE SPOTS TAKEN DURING ACQUISITION, IT SEEMS THAT THERE WAS A MIXED BETWEEN CALIBRATOR SPOT AND SAMPLE B3 SPOT. BASED ON THIS ANALYSIS, THE IDENTIFICATION ISSUE IS RELATED TO A ¿NON-OPTIMAL SPOT PREPARATION¿. ACCORDING TO DATA ABOVE, THERE IS NO RECONSIDERATION OF VITEK MS PRIME INSTRUMENT (REF. 423281, SERIAL NUMBER (B)(6)) PERFORMANCE.

    Description of Event or Problem · 0

    INTENDED USE: VITEK® MS PRIME IS A MASS SPECTROMETRY SYSTEM USING MATRIX-ASSISTED LASER DESORPTION/IONIZATION TIME OF FLIGHT MASS SPECTROMETRY (MALDI-TOF MS) FOR THE IDENTIFICATION OF MICROORGANISMS CULTURED FROM HUMAN SPECIMENS. THE VITEK® MS PRIME SYSTEM IS A QUALITATIVE IN VITRO DIAGNOSTIC DEVICE INDICATED FOR USE IN CONJUNCTION WITH OTHER CLINICAL AND LABORATORY FINDINGS TO AID IN THE DIAGNOSIS OF BACTERIAL AND FUNGAL INFECTIONS. ISSUE DESCRIPTION: A CUSTOMER IN PORTUGAL REPORTED TO BIOMÉRIEUX THAT THEY HAVE OBTAINED A POTENTIAL MISIDENTIFICATION OF STREPTOCOCCUS CONSTELLATUS AS E. COLI WHILE USING VITEK MS PRIME (REF. (B)(4), SERIAL NUMBER (B)(4)). IT WAS REPORTED THAT THE CUSTOMER OBTAINED A POTENTIAL MISIDENTIFICATION WITH A PLEURAL LIQUID SAMPLE WHERE THEY SUSPECTED THAT THE COLONY WAS A STREPTOCOCCUS. THE FIRST TEST RESULT PROVIDED BY VITEK MS PRIME WAS ESCHERICHIA COLI AND THE REPEAT TEST RESULT WAS STREPTOCOCCUS CONSTELLATUS, WHICH WAS THE EXPECTED RESULT. IT WAS REPORTED THAT FOR THE SECOND TEST, THE CULTURE WAS A SUBCULTURE OF THE ORIGINAL PLATE IN COS, PVX AND MCK. SUMMARY: VITEK® MS PRIME FIRST TEST RESULT = E. COLI (LEVEL OF CONFIDENCE NOT REPORTED). VITEK® MS PRIME SECOND TEST RESULT = STREPTOCOCCUS CONSTELLATUS. CUSTOMER¿S EXPECTED RESULT = STREPTOCOCCUS CONSTELLATUS. IT WAS REPORTED THAT THE CUSTOMER DIDN¿T CONFIRM THE EXPECTED IDENTIFICATION VIA REFERENCE METHOD; THEY SUSPECTED THERE WAS A POTENTIAL MISIDENTIFICATION OF E. COLI ACCORDING TO THE GRAM STAIN RESULT THEY HAD OBTAINED FOR THE STRAIN IN QUESTION. IN THIS CASE, AT THE TIME OF ASSESSMENT, THERE IS A SUSPICION OF USER ERROR; HOWEVER, ANALYSIS MUST BE CONDUCTED IN ORDER TO DETERMINE THE CAUSE. ADDITIONAL INFORMATION HAVE BEEN REQUESTED TO FURTHER INVESTIGATE THE CUSTOMER¿S COMPLAINT. AT THE TIME OF THE ASSESSMENT, THERE IS NO INDICATION OR REPORT FROM THE CUSTOMER THAT THIS EVENT LED TO ANY ADVERSE EVENT RELATED TO ANY PATIENT'S STATE OF HEALTH. AN INVESTIGATION HAS BEEN INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1690497 VITEK MS PRIME VITEK MS PRIME QBN BIOMÉRIEUX, SA 423281 03573026611422

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown