BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITEK MS INSTRUMENT

    MDR report key: 11646993 · Received April 11, 2021

    Report

    Report Number
    9615754-2021-00048
    Event Type
    Malfunction
    Date Received
    April 11, 2021
    Report Date
    April 11, 2021
    Manufacturer
    BIOMÉRIEUX, SA
    Product Code
    QBN
    UDI-DI
    03573026359119
    PMA / PMN Number
    K181412
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A BIOMÉRIEUX INTERNAL INVESTIGATION WAS INITIATED IN RESPONSE TO THIS COMPLAINT OF OBTAINING DISCREPANT IDENTIFICATION RESULTS WHEN TESTING SEVERAL SAMPLES WITH THE VITEK® MS (REF 410895, SERIAL (B)(4)). THE CUSTOMER'S RAW DATA WAS EVALUATED FOR THIS INVESTIGATION. FINE TUNING: NO FINE TUNING WAS NEEDED DURING THE CUSTOMER'S TESTS. SPOT PREPARATION QUALITY: THE CUSTOMER'S SPOT PREPARATION WAS NON-OPTIMAL. THE CALIBRATOR "ALL PEAKS" VALUES AND SAMPLE "ALL PEAKS" VALUES ARE QUITE HETEROGENOUS. MOST OF THE "ALL PEAKS" VALUES BETWEEN THE FIRST TESTS AND RE-TESTS WERE DIFFERENT. SAMPLE DATA ANALYSIS: THE INVESTIGATION DID NOT IDENTIFY ANY EVIDENCE THAT THE INSTRUMENT MIXED UP THE RESULTS WITH INCORRECT SAMPLE IDENTIFICATIONS. THE POTENTIAL CAUSES FOR DIFFERENCES IN THE IDENTIFICATIONS OBTAINED WERE DETERMINED TO BE NON-OPTIMAL SPOT PREPARATION, SHORT INCUBATION TIME, USE OF A MIXED CULTURE THE CUSTOMER STATED THAT MOST SAMPLES ARE INCUBATED FOR 12 HOURS INSTEAD OF THE BIOMÉRIEUX RECOMMENDED 18-72 HOURS. LOW INCUBATION TIME COULD AFFECT BACTERIA PROTEIN EXPRESSION. SUSPECTED CAUSE(S): NON OPTIMAL SPOT PREPARATION. OPERATOR ERROR (INCORRECT INCUBATION TIME). CONCLUSION: THE EXPECTED IDENTIFICATIONS FOR EACH SAMPLE REMAIN UNKNOWN AS REFERENCE METHOD TESTING HAS NOT BEEN COMPLETED. IT IS RECOMMENDED TO CONFIRM THE IDENTIFICATION BY SEQUENCING. LOCAL CUSTOMER SERVICE (LCS) HAS BEEN REQUESTED TO PROVIDE THE CUSTOMER WITH ADDITIONAL TRAINING MATERIALS TO HELP TO IMPROVE SPOT PREPARATION TECHNIQUE AND TO REMIND THE CUSTOMER OF THE CULTURE REQUIREMENTS FOR INCUBATION TIME (18-72 HOURS).

    Description of Event or Problem · 1

    A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF OBTAINING DISCREPANT IDENTIFICATION RESULTS WHEN TESTING SEVERAL SAMPLES WITH THE VITEK® MS (REF 410895, SERIAL (B)(4)). THE CUSTOMER REPORTED SUSPECTED MIS-IDENTIFICATION RESULTS WHEN TESTING ONE SLIDE. THE OPERATOR REBOOTED THE ACQUISITION PC AND THE VITEK MS INSTRUMENT AND THEN RAN A TEST SLIDE WITH ONE E.COLI CALIBRATION SPOT AND TWO E.COLI TEST SPOTS AND THEY WERE GREEN (ACCEPTABLE) IN THE ACQUISITION STATION. THE CUSTOMER PERFORMED A SECOND ACQUISITION OF THE SAMPLES. NONE OF THE SAMPLES GOT THE SAME RESULT IN THE 1ST AND 2ND TEST. POTENTIAL MISIDENTIFICATIONS - CUSTOMER IS SUSPECTING THAT THE SYSTEM MIXED UP THE RESULTS WITH WRONG SAMPLE IDS FOR ONE SAMPLE SLIDE. VITEK MS RESULT: (B)(6): FIRST TEST (B)(6) = SINGLE CHOICE TO STAPHYLOCOCCUS AUREUS. SECOND TEST (B)(6) = NO IDENTIFICATION. THIRD TEST (B)(6) = SINGLE CHOICE TO STAPHYLOCOCCUS AUREUS. SUSPECTED IDENTIFICATION = UNKNOWN. (B)(6) : FIRST TEST (B)(6) = SINGLE CHOICE TO STAPHYLOCOCCUS HAEMOLYTICUS. SECOND TEST (B)(6) = LOW DISCRIMINATION TO STREPTOCOCCUS DYSGALACTIAE SSP. DYSGALACTIAE - STREPTOCOCCUS DYSGALACTIAE SSP EQUISIMILIS. SUSPECTED IDENTIFICATION = UNKNOWN. (B)(6): FIRST TEST (B)(6) = SINGLE CHOICE TO ENTEROCOCCUS FAECIUM. SECOND TEST (B)(6) = NO IDENTIFICATION. SUSPECTED IDENTIFICATION = LOOKS LIKE STREPTOCOCCUS AGALACTIAE ON THE PLATE. (B)(6): FIRST TEST (B)(6) = SINGLE CHOICE TO STREPTOCOCCUS AGALACTIAE. SECOND TEST (B)(6) = SINGLE CHOICE TO STAPHYLOCOCCUS CAPITIS. THIRD TEST (B)(6) = SINGLE CHOICE TO CORYNEBACTERIUM TUBERCULOSTEARICUM. SUSPECTED IDENTIFICATION = LOOKS LIKE STAPHYLOCOCCUS ON THE PLATE. (B)(6): FIRST TEST (B)(6) = NO IDENTIFICATION. SECOND TEST (B)(6) = NO IDENTIFICATION. SUSPECTED IDENTIFICATION = LOOKS LIKE STAPHYLOCOCCUS ON THE PLATE. (B)(6) : FIRST TEST (B)(6) = SINGLE CHOICE TO STAPHYLOCOCCUS SIMULANS. SECOND TEST (B)(6) = NO IDENTIFICATION. SUSPECTED IDENTIFICATION = LOOKS LIKE STAPHYLOCOCCUS ON THE PLATE. (B)(6) : FIRST TEST (B)(6) = LOW DISCRIMINATION TO ENTEROBACTER CLOACAE - ENTEROBACTER ASBURIAE. SECOND TEST (B)(6) = SINGLE CHOICE TO ENTEROCOCCUS FAECIUM. SUSPECTED IDENTIFICATION = UNKNOWN (VERY SMALL GROWTH ON THE PLATE). (B)(6) : FIRST TEST (B)(6) = LOW DISCRIMINATION TO ENTEROBACTER CLOACAE - ENTEROBACTER ASBURIAE. SECOND TEST (B)(6) = SINGLE CHOICE TO STREPTOCOCCUS AGALACTIAE. SUSPECTED IDENTIFICATION = UNKNOWN (VERY SMALL GROWTH ON THE PLATE). (B)(6) : FIRST TEST (B)(6) =SINGLE CHOICE TO PROTEUS MIRABILIS. SECOND TEST (B)(6) = COULD NOT BE RERUN. SUSPECTED IDENTIFICATION = LOOKS LIKE STREPTOCOCCUS ON THE PLATE. (B)(6) : FIRST TEST (B)(6) = NO IDENTIFICATION. SECOND TEST (B)(6) = SINGLE CHOICE TO STAPHYLOCOCCUS SIMULANS. SUSPECTED IDENTIFICATION = UNKNOWN. (B)(6) : FIRST TEST (B)(6) = NO IDENTIFICATION. SECOND TEST (B)(6) = LOW DISCRIMINATION TO ENTEROBACTER CLOACAE - ENTEROBACTER ASBURIAE. SUSPECTED IDENTIFICATION = LOOKS LIKE ENTEROBACTERIA ON THE PLATE. (B)(6) : FIRST TEST (B)(6) = NO IDENTIFICATION. SECOND TEST (B)(6) = LOW DISCRIMINATION TO ENTEROBACTER CLOACAE - ENTEROBACTER ASBURIAE. SUSPECTED IDENTIFICATION = LOOKS LIKE ENTEROBACTERIA ON THE PLATE. (B)(6) : FIRST TEST (B)(6) = NO IDENTIFICATION. SECOND TEST (B)(6) = SINGLE CHOICE TO PROTEUS MIRABILIS. SUSPECTED IDENTIFICATION = LOOKS LIKE PROTEUS ON THE PLATE. 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. THIS ISSUE WAS INITIALLY REPORTED WITH MDR 9615754-2021-00032. AT THE TIME OF REPORTING, THE NUMBER OF AFFECTED PATIENTS WAS NOT KNOWN. ON 22-MAR-2021 THE CUSTOMER PROVIDED CLARIFICATION THAT NINE (9) PATIENT SAMPLES WERE IMPACTED BY THIS ISSUE. EIGHT ADDITIONALLY EMDRS ARE BEING SUBMITTED FOLLOWING THIS NOTIFICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    544087 VITEK MS INSTRUMENT VITEK® MS INSTRUMENT QBN BIOMÉRIEUX, SA 410895 03573026359119

    Patients

    Seq Age Sex Outcome Treatment
    1