BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITEK® 2 AST -P654 TEST KIT

    MDR report key: 8120814 · Received November 30, 2018

    Report

    Report Number
    1950204-2018-00615
    Event Type
    Malfunction
    Date Received
    November 30, 2018
    Report Date
    April 1, 2019
    Manufacturer
    BIOMERIEUX, INC.
    Product Code
    LON
    PMA / PMN Number
    N50510: S117
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    VITEK® 2 AST -P654 TEST KIT (LOT 8040803203). THE CUSTOMER'S (B)(6) STRAINS WERE CONFIRMED BY PCR MECA (B)(6). THE REFERENCE METHOD FOR OXACILLIN (AGAR DILUTION) GAVE A SUSCEPTIBLE RESULT (MIC = 2 MG/L) FOR S1 AND A RESISTANT RESULT (MIC = 8 MG/L) FOR S2. TESTS WERE PERFORMED ON THE AST-P654 CARD AND SYSTEM VITEK 2 V8.01 (AES PARAMETERS : EUCAST + PHENOTYPIC). THREE AST-P654 CARDS (CUSTOMER LOT 1 # 80408032033,CL1, CUSTOMER LOT 2 # 804082220,CL2 AND A RANDOM LOT # 8040900103, RL) WERE TESTED FROM CBA (COS BMX) SUBCULTURE : S1 : OXA MIC = 1 MG/L S WAS CORRECTED TO R* BY AES SOFTWARE ON THE THREE LOTS TESTED. THESE OXA VALUES ARE WITHIN ESSENTIAL AGREEMENT (<1DOUBLING DILUTION) COMPARED TO THE REFERENCE MIC (1 S) WITHOUT ANY CATEGORY ERROR. OXSF (CEFOXITIN SCREEN) TEST RESULTS WERE OBTAINED POSITIVE ON THE THREE LOTS TESTED. OXSF AND OXA TEST RESULTS WORK TOGETHER TO ALLOW THE DETECTION OF MRSA PHENOTYPE. THE (B)(6) STRAIN WAS CORRECTLY IDENTIFIED FOR S1: "MODIFICATION OF PBP (MECA)" PHENOTYPE GIVEN BY THE AES. S2 : OXA MIC = 1 MG/L S CORRECTED TO R* BY AES ON BOTH CUSTOMER LOTS. THESE OXA VALUES ARE ESSENTIAL AGREEMENT ERRORS (>1DOUBLING DILUTION) COMPARED TO THE REFERENCE MIC (8 R). OX MIC > 4 MG/L R ON THE RL. THIS OXA VALUE IS WITHIN ESSENTIAL AGREEMENT (<1DOUBLING DILUTION) COMPARED TO THE REFERENCE MIC (4 R). OXSF TEST RESULTS WERE OBTAINED POSITIVE ON THE THREE LOTS TESTED. OXSF AND OXA TEST RESULTS WORK TOGETHER TO ALLOW THE DETECTION OF (B)(6) PHENOTYPE. THE (B)(6) STRAIN WAS CORRECTLY IDENTIFIED FOR S2: "MODIFICATION OF PBP (MECA)" PHENOTYPE GIVEN BY THE AES. CONCLUSION : THE CUSTOMER 'S SUSCEPTIBLE OXACILLIN RESULTS ON THE AST-P654 CARD WERE REPRODUCED INTERNALLY. THOSE SUSCEPTIBLE RESULTS ARE IN AGREEMENT WITH THE REFERENCE METHOD FOR S1. AN UNDERESTIMATION OF OXACILLIN IS CONFIRMED FOR S2 ON THE TWO CUSTOMERS LOTS, WITH RESULTS IN AGREEMENT WITH THE REFERENCE METHOD ON THE RANDOM LOT. (B)(6) STRAINS S1 AND S2 ARE CORRECTLY IDENTIFIED BY THE AES PHENOTYPE "MODIFICATION OF PBP (MEC A). THE POSITIVE OXSF TESTS LEAD TO THE CORRECT DETECTION OF (B)(6) FOR BOTH STRAINS. THE VITEK 2 AST-P654 CARDS PERFORMED AS INTENDED. THE OXACILLIN AND CEFOXITIN SCREEN TESTS WORK TOGETHER TO DETERMINE THE FINAL OXACILLIN STATUS. FOR S. AUREUS, IF EITHER OXACILLIN IS R, OR CEFOXITIN SCREEN IS POSITIVE, THE OXACILLIN INTERPRETATION IS R. OXACILLIN MIC TESTING ALONE IS NOT ALWAYS ADEQUATE TO DETECT RESISTANCE. THEREFORE, THE CEFOXITIN SCREEN TEST IS USED IN CONJUNCTION WITH OXACILLIN, IN ORDER TO HAVE OPTIMAL METHICILLIN RESISTANCE DETECTION.

    Additional Manufacturer Narrative · 1

    AN INTERNAL INVESTIGATION WAS PERFORMED FOR FALSE SUSCEPTIBLE OXACILLIN (OXA) RESULTS FOR TWO PATIENT STAPHYLOCOCCUS AUREUS STRAINS (S1-S2), IN ASSOCIATION WITH THE VITEK® 2 AST -P654 TEST KIT (LOT 8040803203). THE CUSTOMER'S (B)(6) STRAINS WERE CONFIRMED BY PCR MECA (B)(6). THE REFERENCE METHOD FOR OXACILLIN (AGAR DILUTION) GAVE A SUSCEPTIBLE RESULT (MIC = 2 MG/L) FOR S1 AND A RESISTANT RESULT (MIC = 8 MG/L) FOR S2. TESTS WERE PERFORMED ON THE AST-P654 CARD AND SYSTEM VITEK 2 V8.01 (AES PARAMETERS : EUCAST + PHENOTYPIC). THREE AST-P654 CARDS (CUSTOMER LOT 1 # 80408032033,CL1, CUSTOMER LOT 2 # 804082220,CL2 AND A RANDOM LOT # 8040900103, RL) WERE TESTED FROM CBA (COS BMX) SUBCULTURE : S1 : OXA MIC = 1 MG/L S WAS CORRECTED TO R* BY AES SOFTWARE ON THE THREE LOTS TESTED. THESE OXA VALUES ARE WITHIN ESSENTIAL AGREEMENT (<1DOUBLING DILUTION) COMPARED TO THE REFERENCE MIC (1 S) WITHOUT ANY CATEGORY ERROR. OXSF (CEFOXITIN SCREEN) TEST RESULTS WERE OBTAINED POSITIVE ON THE THREE LOTS TESTED. OXSF AND OXA TEST RESULTS WORK TOGETHER TO ALLOW THE DETECTION OF (B)(6) PHENOTYPE. THE (B)(6) STRAIN WAS CORRECTLY IDENTIFIED FOR S1: "MODIFICATION OF PBP (MECA)" PHENOTYPE GIVEN BY THE AES. S2 : OXA MIC = 1 MG/L S CORRECTED TO R* BY AES ON BOTH CUSTOMER LOTS. THESE OXA VALUES ARE ESSENTIAL AGREEMENT ERRORS (>1DOUBLING DILUTION) COMPARED TO THE REFERENCE MIC (8 R). OX MIC > 4 MG/L R ON THE RL. THIS OXA VALUE IS WITHIN ESSENTIAL AGREEMENT (<1DOUBLING DILUTION) COMPARED TO THE REFERENCE MIC (4 R). OXSF TEST RESULTS WERE OBTAINED POSITIVE ON THE THREE LOTS TESTED. OXSF AND OXA TEST RESULTS WORK TOGETHER TO ALLOW THE DETECTION OF MRSA PHENOTYPE. THE (B)(6) STRAIN WAS CORRECTLY IDENTIFIED FOR S2: "MODIFICATION OF PBP (MECA)" PHENOTYPE GIVEN BY THE AES. CONCLUSION : THE CUSTOMER 'S SUSCEPTIBLE OXACILLIN RESULTS ON THE AST-P654 CARD WERE REPRODUCED INTERNALLY. THOSE SUSCEPTIBLE RESULTS ARE IN AGREEMENT WITH THE REFERENCE METHOD FOR S1. AN UNDERESTIMATION OF OXACILLIN IS CONFIRMED FOR S2 ON THE TWO CUSTOMERS LOTS, WITH RESULTS IN AGREEMENT WITH THE REFERENCE METHOD ON THE RANDOM LOT. (B)(6) STRAINS S1 AND S2 ARE CORRECTLY IDENTIFIED BY THE AES PHENOTYPE "MODIFICATION OF PBP (MEC A). THE POSITIVE OXSF TESTS LEAD TO THE CORRECT DETECTION OF (B)(6) FOR BOTH STRAINS. THE VITEK 2 AST-P654 CARDS PERFORMED AS INTENDED. THE OXACILLIN AND CEFOXITIN SCREEN TESTS WORK TOGETHER TO DETERMINE THE FINAL OXACILLIN STATUS. FOR S. AUREUS, IF EITHER OXACILLIN IS R, OR CEFOXITIN SCREEN IS POSITIVE, THE OXACILLIN INTERPRETATION IS R. OXACILLIN MIC TESTING ALONE IS NOT ALWAYS ADEQUATE TO DETECT RESISTANCE. THEREFORE, THE CEFOXITIN SCREEN TEST IS USED IN CONJUNCTION WITH OXACILLIN, IN ORDER TO HAVE OPTIMAL METHICILLIN RESISTANCE DETECTION.

    Description of Event or Problem · 1

    A CUSTOMER IN (B)(6) REPORTED (B)(6) RESULTS FOR TWO PATIENT STAPHYLOCOCCUS AUREUS STRAINS, IN ASSOCIATION WITH THE VITEK® 2 AST-P654 TEST KIT (LOT 8040803203).THE CUSTOMER STATED THE CEFOXITIN SCREEN WAS (B)(6). TEST RESULTS WERE: STRAIN (B)(6): (B)(6)-SCREEN-AGAR ("OXIOD") (B)(6), PBP2A NEGATIVE, MERLIN BMD SYSTEM (B)(6), VITEK: CEFOXITIN-SCREEN POSITIVE, (B)(6). STRAIN (B)(6): (B)(6)-SCREEN-AGAR (OXOID) (B)(6), PBP2A NEGATIVE, MERLIN (B)(6), VITEK: CEFOXITIN-SCREEN POSITIVE, (B)(6). THERE IS NO INDICATION OR REPORT FROM THE HOSPITAL OR TREATING PHYSICIAN TO BIOMÉRIEUX 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
    959929 VITEK® 2 AST -P654 TEST KIT VITEK® 2 AST -P654 TEST KIT LON BIOMERIEUX, INC. 8040803203

    Patients

    Seq Age Sex Outcome Treatment
    1