BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITEK® 2 AST -P654 TEST KIT

    MDR report key: 8120817 · Received November 30, 2018

    Report

    Report Number
    1950204-2018-00613
    Event Type
    Malfunction
    Date Received
    November 30, 2018
    Report Date
    April 1, 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 FOR A FALSE POSITIVE CEFOXITIN SCREEN FOR TWO PATIENT STAPHYLOCOCCUS AUREUS STRAINS, IN ASSOCIATION WITH THE VITEK® 2 AST -P654 TEST KIT (LOT 8040803203). IT WAS NOTED THE CUSTOMER WAS TESTING FROM NON-VALIDATED MEDIA, (B)(6) SCREENING AGAR. THE CUSTOMER'S STRAINS WERE CONFIRMED BY REFERENCE METHODS TO DETERMINE THE INTENDED RESULT : PCR MECA/MECC TO CHECK THE ABSENCE OF (B)(6) STRAIN (ASSAY LBMSC-AST-90) WAS NEGATIVE FOR BOTH STRAINS. 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] WAS SUSCEPTIBLE FOR BOTH STRAINS (S1 : D = 27.5MM; S2 : D = 26MM). TESTS 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. NEGATIVE OXSF RESULTS WERE OBTAINED FOR BOTH LOTS AND BOTH STRAINS TESTED. THE NEGATIVE OXSF TESTS CORRELATED WITH THE DISC DIFFUSION RESULT OF SUSCEPTIBLE.(FOX KB S). CONCLUSION THE CUSTOMER FALSE POSITIVE OXSF RESULTS WERE NOT REPRODUCED INTERNALLY. THE VITEK 2 AST-P654 CARDS PERFORMED AS EXPECTED.

    Description of Event or Problem · 1

    A CUSTOMER IN (B)(6) REPORTED A FALSE POSITIVE CEFOXITIN SCREEN 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 POSITIVE WITH (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 OXACILLIN MIC 0.5, 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
    959936 VITEK® 2 AST -P654 TEST KIT VITEK® 2 AST -P654 TEST KIT LON BIOMERIEUX, INC. 8040803203

    Patients

    Seq Age Sex Outcome Treatment
    1