BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITEK® 2 AST-P631

    MDR report key: 7378364 · Received March 28, 2018

    Report

    Report Number
    1950204-2018-00122
    Event Type
    Malfunction
    Date Received
    March 28, 2018
    Report Date
    May 22, 2018
    Manufacturer
    BIOMERIEUX INC.
    Product Code
    LON
    PMA / PMN Number
    N50510:S 117
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A CUSTOMER IN (B)(6) HAD NOTIFIED BIOMÉRIEUX OF FALSE SUSCEPTIBLE RESULTS REGARDING OXACILLIN FOR A STAPHYLOCOCCUS AUREUS ISOLATE ASSOCIATED WITH VITEK® 2 AST-P631 (REFERENCE 414961). AN INTERNAL BIOMÉRIEUX INVESTIGATION WAS PERFORMED USING THE ISOLATE SUBMITTED BY THE CUSTOMER. THE PRESENCE OF A (B)(6) STRAIN WAS CONFIRMED BY PCR MECA POSITIVE AND KIRBY BAUER CEFOXITIN (FOX KB). THE REFERENCE METHOD (AGAR DILUTION) FOR OXACILLIN (OX) GAVE SUSCEPTIBLE RESULTS (OX MIC VALUE = 2 MG/L S). THE BROTH MICRODILUTION (BMD) FOR CEFOXITIN (FOX) GAVE MIC = 4 MG/L S. TESTS PERFORMED ON THE VITEK® 2 AST-P631 CARD AND SYSTEM VITEK 2 V7.01 IMPACTED: THE INCRIMINATED LOT 7310381103 WAS NOT AVAILABLE IN-HOUSE. TWO VITEK 2 AST-P631 CARDS, LOT #7310514103 AND LOT #7310555203, WERE TESTED FROM CBA (COS BIOMÉRIEUX) SUBCULTURE. FOR BOTH LOTS: OX MIC = 2 MG/L S OXSF NEGATIVE TEST PHENOTYPE "ACQUIRED PENICILLINASE OR MODIFICATION OF PBP" GIVE BY AES BIOART RULE N°34 TRIGGERED INSTRUCTING USER TO PERFORM CONFIRMATORY TESTS NOTE: OFLOXACIN R THE OX VALUES ARE WITHIN ESSENTIAL AGREEMENT COMPARED TO THE REFERENCE MIC (2 MG/L), AND NO CATEGORY ERROR. THE OXSF NEGATIVE TESTS ARE NOT CORRELATED WITH THE DISC DIFFUSION RESULT (FOX KB R). THE COMBINATION OF OX MIC = 2 MG/L AND AN OXSF TEST NEGATIVE TRIGGERS THE BIOART RULE N°34 AND THE AES PHENOTYPE "ACQUIRED PENICILLINASE OR MODIFICATION OF PBP". ADDITIONALLY TESTING USING VITEK 2 SYSTEM SOFTWARE VERSION 8.01OBTAINED OXSF TEST POSITIVE ON BOTH LOTS. CONCLUSION: THE CUSTOMER RESULTS WERE REPRODUCED INTERNALLY CONCERNING OXACILLIN SUSCEPTIBLE RESULTS, BUT NOT IN REGARD TO THE OXSF RESULT, WHICH WAS OBTAINED IN-HOUSE NEGATIVE; WHEREAS, THE CUSTOMER AND THE REFERENCE LAB OBTAINED POSITIVE. ON VITEK 2 V7.01 VERSION, BIOART RULES AND AES ARE TRIGGERED, ALERTING FOR THE POTENTIAL PRESENCE OF AN (B)(6) STRAIN. THE INVESTIGATION CONCLUDED THE SYSTEM PERFORMED AS INTENDED FOR THIS ATYPICAL (LATE GROWTH) STAPHYLOCOCCUS AUREUS STRAIN.

    Description of Event or Problem · 1

    A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF DISCREPANT RESULTS ASSOCIATED WITH VITEK® 2 AST-P631 (REFERENCE (B)(4)). THE CUSTOMER REPORTED FALSE SUSCEPTIBLE RESULTS REGARDING MSSA OXACILLIN, MIC 2, FOR A STAPHYLOCOCCUS AUREUS ISOLATE. 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
    222601 VITEK® 2 AST-P631 VITEK® 2 AST-P631 LON BIOMERIEUX INC. 7310381103

    Patients

    Seq Age Sex Outcome Treatment
    1