BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITEK MASS SPECTROMETER

    MDR report key: 6946295 · Received October 12, 2017

    Report

    Report Number
    3002769706-2017-00297
    Event Type
    Malfunction
    Date Received
    October 12, 2017
    Report Date
    January 30, 2018
    Manufacturer
    BIOMERIEUX, SA
    Product Code
    PEX
    UDI-DI
    03573026359119
    PMA / PMN Number
    DEN130013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    A CUSTOMER IN (B)(6) HAD NOTIFIED BIOMÉRIEUX OF DISCREPANT IDENTIFICATION RESULTS IN ASSOCIATION WITH THE VITEK® MS INSTRUMENT (REFERENCE 410895). WHEN TESTING A PATIENT ISOLATE, VITEK MS GAVE THE FOLLOWING RESULTS: (B)(6) 2017: SPOT K1_2499 => H.INFLUENZAE (95%), (B)(6) 2017: SPOT K1_2500 REFIRED => H.INFLUENZAE (78%), (B)(6) 2017: SPOT A4_2503 => H.HAEMOLYTICUS (99.9%), (B)(6) 2017: SPOT H2_2504 => H.HAEMOLYTICUS/INFLUENZAE (LOW COMPLIANCE). A BIOMÉRIEUX INTERNAL INVESTIGATION WAS PERFORMED. THE CUSTOMER DID NOT SUBMIT THE ISOLATE FOR FURTHER EVALUATION. DATA SUBMITTED BY THE CUSTOMER WAS ANALYZED. => CONCLUSION ON THE SYSTEM: SYSTEM WAS OPERATIONAL DURING THE TEST. => CONCLUSION ON THE IDENTIFICATION: REGARDING THE CUSTOMER DATA PROVIDED, THE MOST PROBABLE IDENTIFICATION IS HAEMOPHILUS INFLUENZA (BASED ON THE GRAM STRAINING AND MORPHOLOGY). HOWEVER, THE STRAIN RETURN WAS NOT POSSIBLE FOR FURTHER INVESTIGATION. SO, FOR THIS CASE, IT WAS NOT POSSIBLE TO CONCLUDE ON THE SAMPLE IDENTIFICATION. THERE IS A SPECIFIC LIMITATION IN THE KNOWLEDGE BASE (KB) USER MANUAL FOR VITEK MS CLINICAL USE V3.0 REGARDING HAEMOPHILUS HAEMOLYTICUS: "ORGANISMS WITH LOWER ACCURACY OF IDENTIFICATION - IMPORTANT: CONFIRM IDENTIFICATION OF THESE ORGANISMS WITH AN ALTERNATE METHOD." AS THE CUSTOMER HAD OBTAINED A SINGLE CHOICE TO HAEMOPHILUS HAEMOLYTICUS AFTER RETEST, THE RECOMMENDATIONS LISTED IN THE VITEK MS KB USER MANUAL SHOULD BE FOLLOWED AND AN ALTERNATE METHOD TO CONFIRM THE IDENTIFICATION SHOULD BE PERFORMED. IN THIS CASE, THE REFERENCE MOLECULAR METHOD IS SEQUENCING. => SUSPECTED ROOT CAUSE OF THE ISSUE: * WITHOUT THE RETURN OF CUSTOMER STRAIN, IT IS NOT POSSIBLE TO DEFINE THE ROOT CAUSE OF THE IDENTIFICATION ISSUE. * DURING THE INVESTIGATION, IT HAS BEEN FOUND THAT THE "ALL PEAKS" ARE HETEROGENEOUS. SO, THE QUALITY OF SPOT PREPARATION HAS TO BE OPTIMIZED.

    Description of Event or Problem · 1

    A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF DISCREPANT IDENTIFICATION RESULTS IN ASSOCIATION WITH VITEK® MS INSTRUMENT (REFERENCE 410895). WHEN TESTING A PATIENT ISOLATE, VITEK® MS ORIGINALLY GAVE AN IDENTIFICATION OF HAEMOPHILUS INFLUENZAE (95%). THEY RETESTED WITH AN ID RESULT OF H. INFLUENZAE 78%. THE ORGANISM WAS SUB-CULTURED AND TESTING REPEATED WITH A VITEK® MS ID RESULT OF HAEMOPHILUS HAEMOLYTICUS 99.9%. THE TECHNOLOGIST STRONGLY SUSPECTED H. INFLUENZAE DUE TO GRAMSTAIN, MORPHOLOGY, ETC. SO TESTING WAS REPEATED, GIVING 50/50 HAEMOLYTICUS/INFLUENZAE. IT WAS THEN REFIRED AND GAVE H. INFLUENZA 99.9%. CUSTOMER STATED THAT THERE WAS NO EFFECT ON REPORTING OF PATIENT RESULTS. THERE IS NO INDICATION OR REPORT FROM THE LABORATORY THAT THE DISCREPANT RESULT LED TO ANY ADVERSE EVENT RELATED TO THE PATIENT'S STATE OF HEALTH. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    725474 VITEK MASS SPECTROMETER VITEK® MS¿ PEX BIOMERIEUX, SA 410895 03573026359119

    Patients

    Seq Age Sex Outcome Treatment
    1