BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITEK MASS SPECTROMETER

    MDR report key: 7110236 · Received December 12, 2017

    Report

    Report Number
    3002769706-2017-00402
    Event Type
    Malfunction
    Date Received
    December 12, 2017
    Report Date
    January 10, 2018
    Manufacturer
    BIOMERIEUX, SA
    Product Code
    PEX
    UDI-DI
    03573026359119
    PMA / PMN Number
    DEN130013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MB
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A CUSTOMER FROM (B)(6) NOTIFIED BIOMÉRIEUX OF A MISIDENTIFICATION OF CANDIDA METAPSILOSIS AS CANDIDA ORTHOPSILOSIS IN ASSOCIATION WITH THE VITEK® MS INSTRUMENT. AN INVESTIGATION WAS PERFORMED. ANALYSIS OF THE INSTRUMENT FILES CONFIRMED THE VITEK MS SYSTEM WAS OPERATIONAL DURING THE CUSTOMER TEST. THE CUSTOMER DATA WAS REPROCESSED WITH THE NEXT VITEK MS KB (KNOWLEDGE BASE) IN DEVELOPMENT AND THE MOST PROBABLE IDENTIFICATION IS CANDIDA METAPSILOSIS. THIS SPECIES (CANDIDA METAPSILOSIS) IS NOT INCLUDED IN THE VITEK MS KB (B)(4) (FOR CLINICAL USE) NOR IN VITEK MS KB (B)(4) (FOR INDUSTRY). THERE IS A SYSTEM LIMITATION IN THE KB USER MANUAL REF. 161150-556-B FOR VITEK MS CLINICAL USE (B)(4): "TESTING OF SPECIES NOT FOUND IN THE DATABASE MAY RESULT IN AN UNIDENTIFIED RESULT OR A MISIDENTIFICATION." VITEK MS SYSTEM IDENTIFICATION IS BASED ON A SPECIES PATTERN CLASSIFICATION. THE SYSTEM LIMITATION IS DUE TO THE USE OF A PREDICTIVE MODELING BASED ON A SUPERVISED LEARNING. TYPICALLY, SUCH A MODEL INCLUDES AN ALGORITHM THAT LEARNS CERTAIN PROPERTIES (PEAKS PRESENCE) FROM A TRAINING SPECTRA DATASET IN ORDER TO MAKE THOSE PREDICTIONS. WHEN THE MICROORGANISM TESTED IS NOT PART OF THE TRAINING DATASET, NO SPECIFIC SPECIES PATTERN WILL BE AVAILABLE IN THE DATABASE FOR COMPARISON. CONSEQUENTLY, THE SYSTEM CAN GIVE: NO IDENTIFICATION (MOST PROBABLE ANSWER) WHEN THE SPECTRUM ACQUIRED DOESN'T MATCH WITH ANY SPECIES PATTERN. AN INCORRECT SINGLE CHOICE IDENTIFICATION TO THE NEAREST PATTERN SPECIES (OFTEN SAME GENUS THAN EXPECTED) WHEN THE SPECTRUM ACQUIRED PRESENTS HIGH LEVEL OF SIMILARITY WITH A SPECIFIC SPECIES PATTERN PRESENT IN THE DATABASE. A LOW DISCRIMINATION IDENTIFICATION (OFTEN THE SAME GENUS THAN EXPECTED) WHEN THE SPECTRUM ACQUIRED PRESENTS HIGH LEVEL OF SIMILARITY WITH MULTIPLE SPECIFIC SPECIES PATTERNS PRESENT IN THE DATABASE. IN ADDITION, REGARDING "NO IDENTIFICATION" RESULTS, THERE IS A COMMENT IN THE WORKFLOW USER MANUAL CLINIC USE REF. 4501-2233-E (IN THE "VITEK MS ACQUISITION/ANALYSIS MESSAGES" SECTION): "[P150] SAMPLE SPOT: NO IDENTIFICATION => REPEAT THE ACQUISITION FOR THE SAME DEPOSIT. IF THE MESSAGE IS DISPLAYED AGAIN, REDO THE DEPOSIT AND THEN THE ACQUISITION. IF THE MESSAGE IS DISPLAYED AGAIN, REPEAT THE IDENTIFICATION USING ANOTHER METHOD (SUCH AS VITEK 2, API STRIP, OTHER BIOCHEMICAL OR MOLECULAR METHODS)." IN THIS CASE, SEQUENCING IS THE REFERENCE MOLECULAR METHOD TO IDENTIFY THE CUSTOMER SAMPLE. FINALLY, THE MISIDENTIFICATION ISSUE OBSERVED BY THE CUSTOMER, ONE "SINGLE CHOICE TO CANDIDA ORTHOPSILOSIS" INSTEAD OF "NO IDENTIFICATION", COULD BE LINKED TO THE NON-OPTIMAL SPOT PREPARATION FOR TEST PERFORMED ON (B)(6) 2017. FOR THE OTHER TESTS PERFORMED ON (B)(6) 2017, (B)(6) 2017 AND (B)(6) 2017, THE SYSTEM GAVE "NO IDENTIFICATION". SO, VITEK MS WORKED AS INTENDED, AS CANDIDA METAPSILOSIS IS NOT INCLUDED NEITHER IN THE VITEK MS KB (B)(4) (FOR CLINICAL USE) NOR IN VITEK MS KB (B)(4) (FOR INDUSTRY).

    Description of Event or Problem · 1

    A CUSTOMER FROM (B)(6) NOTIFIED BIOMÉRIEUX OF A MISIDENTIFICATION OF CANDIDA METAPSILOSIS AS CANDIDA ORTHOPSILOSIS IN ASSOCIATION WITH THE VITEK® MS INSTRUMENT. THE CUSTOMER REPORTED TESTING THE STRAIN EIGHT (8) TIMES IN TOTAL. THE CUSTOMER OBTAINED A NO IDENTIFICATION RESULT FOR THE RE-TESTS. THERE IS NO INDICATION OR REPORT FROM THE LABORATORY OR PHYSICIAN THAT THE DISCREPANT RESULT LED TO ANY ADVERSE EVENT RELATED TO A PATIENT'S STATE OF HEALTH. AN INTERNAL BIOMÉRIEUX INVESTIGATION WILL BE INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    887318 VITEK MASS SPECTROMETER VITEK® MS¿ PEX BIOMERIEUX, SA 410895 03573026359119

    Patients

    Seq Age Sex Outcome Treatment
    1