BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITEK® 2 AST-P580 TEST KIT

    MDR report key: 8094803 · Received November 21, 2018

    Report

    Report Number
    1950204-2018-00564
    Event Type
    Malfunction
    Date Received
    November 21, 2018
    Report Date
    March 11, 2019
    Manufacturer
    BIOMERIEUX, INC.
    Product Code
    LON
    PMA / PMN Number
    K053097
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AN INTERNAL INVESTIGATION WAS PERFORMED FOR FALSE POSITIVE CEFOXITIN SCREEN RESULTS WHEN PERFORMING ANTIBIOTIC SUSCEPTIBILITY TESTING (AST) FOR STAPHYLOCOCCUS AUREUS WITH THE VITEK® 2 AST-P580 TEST KIT (REF. 22233). THE CUSTOMER SUBMITTED THE STRAIN FOR EVALUATION. A REVIEW OF THE CUSTOMER SET UP SHOWED THE CUSTOMER WAS USING OXOID BLOOD AGAR BASE CM0055, WHICH USES A NON-VALIDATED HORSE BLOOD AGAR. IDENTIFICATION OF THE CUSTOMER'S STRAIN WAS CONFIRMED TO STAPHYLOCOCCUS AUREUS WITH THE VITEK GP ID CARD ( LOT 2420822203). REFERENCE METHODS TO DETERMINE THE INTENDED RESULT : KIRBY-BAUER CEFOXITIN (FOX KB), REFERENCE METHOD USED FOR CEFOXITIN SCREEN TEST WITH CLSI DIAMETERS BREAKPOINTS USED IN DEVELOPMENT [>= 22 MM S ; <= 21 MM R] : D = 28 MM (S). AGAR DILUTION FOR OXACILLIN (AD OX), REFERENCE METHOD USED FOR THE DEVELOPMENT OF THE OX101N FORMULARY IN THE AST-580CARD: AD OX MIC = 0.25 MG/L (S). TESTING WAS PERFORMED ON THE AST-P580 CARD AND VITEK 2 V8.01 SYSTEM (AES PARAMETERS : EUCAST + EUCAST BASED) : TWO AST-P580 CARDS (ONE FROM CUSTOMER LOT # 3600635103,CL AND ONE FROM A RANDOM LOT # 3600571203, RL) WERE TESTED FROM CBA (COS BIOMERIEUX) SUBCULTURE : NEGATIVE OXSF TESTS AND "ACQUIRED PENICILLINASE" PHENOTYPES WERE GIVEN BY THE AES ON BOTH LOTS TESTED. THE NEGATIVE OXSF TESTS ARE CORRELATED WITH THE DISC DIFFUSION RESULT (FOX KB S). VITEK 2 OXACILLIN RESULTS : MIC = 0.5 MG/L S ON CL AND MIC <=0.25 MG/L S ON RL. THE VALUES ARE CORRELATED WITHIN 1 DOUBLING DILUTION WITH THE REFERENCE MIC. THE CUSTOMER FALSE POSITIVE OXSF RESULTS ARE NOT REPRODUCED INTERNALLY. THE CUSTOMER USED NON-VALIDATED MEDIA.

    Description of Event or Problem · 1

    A CUSTOMER IN FINLAND NOTIFIED BIOMÉRIEUX OF OBTAINING FALSE POSITIVE CEFOXITIN SCREEN RESULTS WHEN PERFORMING ANTIBIOTIC SUSCEPTIBILITY TESTING (AST) FOR (B)(6) WITH THE VITEK® 2 AST-P580 TEST KIT (REF. 22233). THE CEFOXITIN SCREEN WAS (B)(6), BUT THE OXACILLIN MIC WAS <= 0.25. WHEN RETESTING, THE CUSTOMER OBTAINED A CEFOXITIN SCREEN NEGATIVE RESULT. THE CUSTOMER WAS PERFORMING INITIAL TESTING WITH SA SELECTIVE MEDIA, WHICH IS NOT A VALIDATED MEDIA FOR TESTING WITH THE VITEK 2 AST-P580 CARD AND WOULD BE CONSIDERED OFF-LABEL USE. THE CUSTOMER WAS ASKED TO PERFORM RETESTING ON VALIDATED MEDIA. ON (B)(6) 2018, THE CUSTOMER REPORTED OBTAINING FALSE POSITIVE CEFOXITIN SCREEN WITH INITIAL AND REPEAT TESTING ON AN ISOLATE TESTED FROM A VALIDATED MEDIA AND PROVIDED THE LAB REPORTS FOR EVALUATION. 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
    936841 VITEK® 2 AST-P580 TEST KIT VITEK® 2 AST-P580 TEST KIT LON BIOMERIEUX, INC. 3600635103

    Patients

    Seq Age Sex Outcome Treatment
    1