BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITEK® 2 GRAM-POSITIVE ANTIMICROBIAL SUSCEPTIBILITY TEST AST-P654 TEST KIT

    MDR report key: 8439541 · Received March 21, 2019

    Report

    Report Number
    1950204-2019-00071
    Event Type
    Malfunction
    Date Received
    March 21, 2019
    Date of Event
    January 30, 2019
    Report Date
    May 27, 2019
    Manufacturer
    BIOMERIEUX, INC
    Product Code
    LON
    PMA / PMN Number
    K053097
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AN INTERNAL INVESTIGATION WAS PERFORMED DUE TO A FALSE NEGATIVE CEFOXITIN SCREEN (OXSF) RESULT FOR A STRAIN OF STAPHYLOCOCCUS AUREUS FROM PATIENT ISOLATE ASSOCIATED WITH VITEK 2 V7.01 SOFTWARE, AST-P654 CARDS. THE PRESENCE OF A (B)(6) STRAIN WAS CONFIRMED BY PCR MECA (B)(6) AND KIRBY BAUER CEFOXITIN (FOX KB) RESISTANT. THE REFERENCE METHOD (AGAR DILUTION) FOR OXACILLIN (OX) GAVE SUSCEPTIBLE RESULTS (OX MIC = 0.5 MG/L S). TESTS WERE PERFORMED ON THE AST- P654 CARD AND SYSTEM VITEK 2 V7.01 IMPACTED (AES PARAMETERS : GLOBAL EUROPEAN BASED + PHENOTYPIC) : THREE AST-P654 CARDS (ONE FROM CUSTOMER LOT 1 # 8040900103 (CL1), ONE FROM CUSTOMER LOT 2 # 8040935203 (CL2) AND ONE FROM A LOT USED AS RANDOM LOT #8040873203 (RL)) WERE TESTED FROM CBA (COS BMX) SUBCULTURE : - NEGATIVE OXSF TESTS AND OX MIC = 0.5 MG/L S FOR THE THREE LOTS TESTED. - PHENOTYPE "ACQUIRED PENICILLINASE" GIVEN BY AES. - THE OX VALUES ARE WITHIN ESSENTIAL AGREEMENT COMPARED TO THE REFERENCE AD MIC (0.5 S) WITHOUT ANY CATEGORY ERROR. - THE OXSF NEGATIVE TESTS ARE NOT CORRELATED WITH THE DISC DIFFUSION RESULT (FOX KB R). ON V7.01 VERSION, THE COMBINATION OF OX MIC = 0.5 MG/L AND AN OXSF TEST NEGATIVE DOES NOT ALLOW THE DETECTION OF THE (B)(6) STRAIN. TESTING WAS ALSO PERFORMED USING VITEK 2 V8.01 SOFTWARE, WHICH HAD AN IMPROVED IDENTIFICATION OF (B)(6). CONCLUSION : - CUSTOMER RESULTS WERE REPRODUCED INTERNALLY WITH VITEK 2 V7.01 SOFTWARE, AST-P654 CARDS. - THE STRAIN SHOWS A LATE GROWTH WHICH IS NOT DETECTED ON V7.01 VERSION.

    Description of Event or Problem · 1

    A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF A FALSE NEGATIVE (SUSCEPTIBLE) CEFOXITIN SCREEN (OXSF) RESULT FOR A STAPHYLOCOCCUS AUREUS PATIENT STRAIN IN ASSOCIATION WITH THE VITEK® 2 AST-P654 TEST KIT (LOT 8040900103) AND SOFTWARE VERSION 7.01. THE CUSTOMER STATED THE ASSOCIATED (B)(6) RESULT WAS (B)(6). THE CUSTOMER SENT THE ISOLATE TO A PARTNER LAB FOR CONFIRMATORY TESTING. WITH THE SAME LOT NUMBER AST-P654 TEST KIT AND SOFTWARE VERSION 8.01, THE PARTNER LAB OBTAINED AN OXSF POSITIVE (RESISTANT) RESULT. THE PARTNER LAB ALSO TESTED THE ISOLATE VIA PCR (B)(6); ALL RESULTS WERE (B)(6). THE CUSTOMER RETESTED THE ISOLATE AGAIN USING AST-P654 AND FOUND OXFS NEGATIVE AGAIN. THE CUSTOMER STATED THAT THE PATIENT WAS STARTED ON A PENICILLIN DERIVATE ANTIBIOTIC, BASED ON THE VITEK 2 AST-P654 RESULT OF OXSF NEGATIVE. THE CUSTOMER PROVIDED NO STATEMENT THAT THIS TREATMENT WAS MODIFIED BASED ON THE CONFIRMATORY TEST RESULTS, NOR ANY INFORMATION REGARDING PATIENT RESPONSE TO TREATMENT. 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. THE CUSTOMER'S ISOLATE SUBMITTAL HAS BEEN RECEIVED, AND BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE CONDUCTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    233440 VITEK® 2 GRAM-POSITIVE ANTIMICROBIAL SUSCEPTIBILITY TEST AST-P654 TEST KIT VITEK® 2 AST-P654 CARD LON BIOMERIEUX, INC 8040900103

    Patients

    Seq Age Sex Outcome Treatment
    1