BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITEK® 2 AST-P631 TEST KIT

    MDR report key: 7685628 · Received July 13, 2018

    Report

    Report Number
    1950204-2018-00254
    Event Type
    Malfunction
    Date Received
    July 13, 2018
    Report Date
    August 29, 2018
    Manufacturer
    BIOMERIEUX, INC
    Product Code
    LON
    PMA / PMN Number
    K053097
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AN INTERNAL BIOMÉRIEUX INVESTIGATION WAS PERFORMED DUE TO A DISCREPANT CEFOXITIN SCREEN TEST (OXSF) RESULTS FOR A STAPHYLOCOCCUS AUREUS FROM PATIENT ISOLATE ASSOCIATED WITH VITEK® 2 V7.01 AND V8.01 SOFTWARE, AST-P631 CARD. THE DISC DIFFUSION FOR CEFOXITIN (FOX), WHICH IS THE REFERENCE METHOD FOR OXSF TEST, GAVE : D=19 MM R. THE REFERENCE METHOD (AGAR DILUTION) FOR OXACILLIN (OX) GAVE SUSCEPTIBLE RESULTS (OX MIC = 1 MG/L S). TESTS PERFORMED ON THE VITEK 2 AST-P631 CARD AND SYSTEM VITEK 2 V7.01 IMPACTED (AES PARAMETERS: CASFM EUCAST 2016 + PHENOTYPIC): THREE (3) AST-P631 CARDS (ONE FROM CUSTOMER LOT #7310586203, CL1, ONE FROM CUSTOMER LOT #7310634403, CL2, AND ONE FROM A RANDOM LOT #7310676103,RL) WERE TESTED FROM CBA (COS BMX) SUBCULTURE: - CL1, CL2 AND RL: OX MIC = 1 MG/L S, OXSF NEGATIVE TEST WITH "ACQ PASE OR MODIFICATION OF PBP, ACQUIRED PENICILLINASE" PHENOTYPE. - THE OX VALUES ARE WITHIN ESSENTIAL AGREEMENT COMPARED TO THE REFERENCE MIC (1 MG/L ), AND NO CATEGORY ERROR. - THE NEGATIVE OXSF TESTS ARE NOT CORRELATED WITH THE DISC DIFFUSION RESULT (FOX KB R). TESTS PERFORMED ON THE VITEK 2 AST-P631 CARD AND SYSTEM VITEK 2 V8.01 IMPACTED (AES PARAMETERS: CASFM EUCAST 2018_V1): THREE (3) AST-P631 CARDS (ONE FROM CUSTOMER LOT #7310586203, CL1, ONE FROM CUSTOMER LOT #7310634403, CL2, AND ONE FROM A RANDOM LOT #7310676103,RL) WERE TESTED FROM CBA (COS BMX) SUBCULTURE: - CL1 AND CL2: OX MIC <= 0.25 MG/L S, OXSF NEGATIVE TEST WITH "ACQUIRED PENICILLINASE" PHENOTYPE. - THESE OX VALUES ARE AN ESSENTIAL AGREEMENT ERROR COMPARED TO THE REFERENCE MIC (1 MG/L) WITHOUT CATEGORY ERROR. - RL: OX MIC = 0.5 MG/L S, OXSF NEGATIVE TEST WITH "ACQUIRED PENICILLINASE" PHENOTYPE. - THE OX VALUE IS WITHIN ESSENTIAL AGREEMENT COMPARED TO THE REFERENCE RESULT WITHOUT CATEGORY ERROR. - THE NEGATIVE OXSF TESTS ARE NOT CORRELATED WITH THE DISC DIFFUSION RESULT (FOX KB R). CONCLUSION: CUSTOMER FALSE OXSF NEGATIVE RESULTS IS REPRODUCED INTERNALLY ON BOTH VITEK 2 VERSIONS V7.01 AND V8.01. ROOT CAUSE - NON-IDENTIFIED. LATE GROWTH OF OX WELLS AND NO GROWTH IN CEFOXITIN WELLS LEADS TO NONDETECTION OF MRSA STRAIN.

    Description of Event or Problem · 1

    A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF DISCREPANT RESULTS ASSOCIATED WITH VITEK® 2 AST-P631 (REFERENCE 414961). THE CUSTOMER REPORTED A (B)(6) NOT DETECTED IN 8.01. (B)(6) WAS CONFIRMED USING DISK DIFFUSION AND BY PCR (MECA+). 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
    528728 VITEK® 2 AST-P631 TEST KIT VITEK® 2 AST-P631 TEST KIT LON BIOMERIEUX, INC 7310634403

    Patients

    Seq Age Sex Outcome Treatment
    1