BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITEK® MS

    MDR report key: 6091048 · Received November 9, 2016

    Report

    Report Number
    3002769706-2016-00470
    Event Type
    Malfunction
    Date Received
    November 9, 2016
    Date of Event
    October 8, 2016
    Report Date
    October 2, 2017
    Manufacturer
    BIOMERIEUX SA
    Product Code
    PEX
    PMA / PMN Number
    K124067
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AN INTERNAL BIOMÉRIEUX INVESTIGATION WAS PERFORMED WITH RESULTS AS FOLLOWS: PROBLEM DESCRIPTION: MODE : IVD. KB VERSION : V2. VITEK® MS RESULT : VIBRIO VULNIFICUS. OTHER IDENTIFICATION METHOD: VITEK® GNI =SLASHLINE PSEUDO AERUGINOSA / PSEUDO PUTIDA. API = SLASHLINE PSEUDO AERUGINOSA / PSEUDO PUTIDA. OTHER TESTS INFORMATION: TCBS AGAR = NO GROWTH. GEL = POSITIVE. GROWTH AT 42 DEGREES = POSITIVE. FLORESCENCE = POSITIVE. MAC (MACCONKEY AGAR) PLATE FOR FIRST TEST AND TSA (TRYPTIC SOY AGAR) PLATE. ECAL MZML FILES FROM (B)(6) 2016 SHOW THAT: ALMOST ALL SPECTRA HAVE LESS THAN 80 ALL PEAKS (BELOW FINE TUNING ANALYZER CRITERIA). VARIABILITY BETWEEN ~40 AND ~70 ALL PEAKS. ECAL MZML FILES FROM (B)(6) 2016 SHOW THAT: ALL SPECTRA HAVE MORE THAN 80 PEAKS (ESPECIALLY ON THE (B)(6) 2016, THE ALL PEAKS MINIMUM VALUE IS 83). VARIABILITY BETWEEN ~80 AND ~115 ALL PEAKS (SAME VARIABILITY ON THE (B)(6) 2016). THE MISIDENTIFICATION WAS OBTAINED ON (B)(6) 2016 AND THE CORRECT RESULT (P. PUTIDA) WAS OBTAINED ON (B)(6) 2016 AFTER SAMPLE REPEAT. THE SYSTEM WAS FINE-TUNED ON 3OCT2016 AND 12OCT2016. CONCLUSION- THE SYSTEM WAS NOT OPERATIONAL FOR THE TESTS PERFORMED ON (B)(6) 2016. THE SYSTEM WAS OPERATIONAL FOR THE TESTS PERFORMED ON (B)(6) 2016. REGARDING THE ANALYSIS OF THE DATA PROVIDED, THE MOST PROBABLE IDENTIFICATION IS PS. PUTIDA. SUSPECTED ROOT CAUSE OF THE ISSUE: THE SYSTEM FINE TUNING WAS OUT OF THE ACCEPTANCE CRITERIA WHEN THE MISIDENTIFICATION WAS OBTAINED. KNOWLEDGE BASE (KB) V2 WEAKNESS: THE TWO (2) MISIDENTIFICATIONS WERE OBTAINED WITH IDENTIFICATION SCORES BELOW -0,4 (MOST PROBABLY DUE TO FACTOR DESCRIBED ABOVE). THE ACCEPTANCE CRITERIA TO GIVE AN IDENTIFICATION RESULT IS MINIMUM -0,6 WITH CURRENT 2.0 KB. WITH THE NEXT KBS, THIS ACCEPTANCE CRITERIA HAS BEEN INCREASED TO -0,4 IN ORDER TO REDUCE THE NUMBER OF MISIDENTIFICATIONS. THAT IS WHY THERE IS NO MISIDENTIFICATION WHEN SPECTRA WERE REPROCESSED WITH THE NEXT KB V3.0 AND V3.1 (NOID OBTAINED). REGARDING THE L1 INFORMATION: FIRST TEST WITH VITEK® MS WAS DONE WITH COLONIES FROM MACCONKEY II PLATE. REPEATED TESTS WERE DONE WITH COLONIES FROM TSA PLATE. THE PLATES USED TO PERFORM VITEK MS IDENTIFICATIONS CONTAINED SEVERAL ORGANISMS (PSEUDOMANOS AERUGINOSA, PSEUDOMANOS PUTIDA, AUR AND CORYNEBACTERIUM). ACCORDING TO THE VITEK® MS WORKFLOW USER MANUAL, PARAGRAPH 5 "SAMPLE PREPARATION": "THE MICROORGANISMS TO BE IDENTIFIED MUST FIRST BE ISOLATED ON A SUITABLE CULTURE MEDIUM". THE IDENTIFICATION PROCESS IS BASED ON SPECIFIC PEAKS PRESENCE, IF THE COLONY IS NOT PURE, SOME PEAKS NOT BELONGING TO THE TESTED STRAIN COULD DISTURB THE IDENTIFICATION PROCESS.

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    A CUSTOMER IN THE UNITED STATES CONTACTED BIOMERIEUX TO REPORT A MISIDENTIFICATION OF PSEUDOMONAS AS VIBRIO VULNIFICUS IN ASSOCIATION WITH THE VITEK MS SYSTEM. THE PHYSICIAN QUESTIONED THE ORGANISM IDENTIFICATION OF VIBRIO VULNIFICUS WHEN COMBINED WITH THE REPORTED AST RESULTS. FOLLOW-UP TESTING VIA ALTERNATE METHODS (VITEK 2 GP ID AND API) EACH PROVIDED A LOW DISCRIMINATION IDENTIFICATION TO PSEUDOMONAS AERUGINOSA / PSEUDOMONAS PUTIDA. REPEAT TESTING OF THE ISOLATE VIA VITEK MS (TWO DIFFERENT SYSTEMS, ISOLATE RUN IN DUPLICATE) OBTAINED IDENTIFICATIONS TO THE SPECIES: - PSEUDOMONAS PUTIDA (SYSTEM 1, BOTH SPOTS) - PSEUDOMONAS PUTIDA (SYSTEM 2, BOTH SPOTS), BUT WITH LOWER CONFIDENCE SCORES. THE SPOTS WERE RETESTED AND PROVIDED RESULTS OF LOW DISCRIMINATION PS.PUTIDA / V. VULNIFICUS AND SINGLE CHOICE V. VULNIFICUS. EVALUATION OF THE CUSTOMER-SUBMITTED LOG FILES INDICATED THAT FINE-TUNING SHOULD BE PERFORMED. IN ADDITION, LOW INTENSITIES MAKE THE SPOT QUALITY (USER TECHNIQUE) SUSPECT. THERE IS NO INDICATION OR REPORT FROM THE HOSPITAL OR TREATING PHYSICIAN TO BIOMERIEUX THAT THE DISCREPANT RESULT LED TO ANY ADVERSE IMPACT TO THE PATIENT'S STATE OF HEALTH. AN INTERNAL BIOMERIEUX INVESTIGATION WILL BE INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    741803 VITEK® MS VITEK® MS PEX BIOMERIEUX SA 410895

    Patients

    Seq Age Sex Outcome Treatment
    1