BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITEK® 2 AST-P580 TEST KIT

    MDR report key: 8190144 · Received December 21, 2018

    Report

    Report Number
    1950204-2018-00723
    Event Type
    Malfunction
    Date Received
    December 21, 2018
    Report Date
    April 11, 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 BIOMÉRIEUX INVESTIGATION WAS PERFORMED DUE TO A REPORT OF A FALSE POSITIVE CEFOXITIN SCREEN (OXSF) RESULT FOR A STRAIN OF STAPHYLOCOCCUS AUREUS FROM PATIENT ISOLATES, ASSOCIATED WITH VITEK® 2 SYSTEM V8.01 SOFTWARE, AND THE VITEK® 2 AST-P580 CARD. IDENTIFICATION WAS CONFIRMED FOR THE CUSTOMER'S STRAIN AS STAPHYLOCOCCUS AUREUS WITH 99% PROBABILITY, USING THE VITEK® 2 GP ID CARD (LOT 2420822203), FOR IDENTIFICATION OF GRAM-POSITIVE ORGANISMS. THE FOLLOWING REFERENCE METHODS WERE USED TO DETERMINE THE INTENDED RESULT: · PCR MECA/MECC TO CHECK FOR PRESENCE OF MRSA STRAIN (ASSAY LBMSC-AST-90). RESULT - PCR MECC POSITIVE. · 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] RESULT - DIAMETER = 12 MM, RESISTANT (R). · AGAR DILUTION (AD) METHOD USED FOR OXACILLIN DEVELOPMENT (FORMULATION OX101N) ON AST-P580 CARD RESULT - OXACILLIN (OX) MINIMUM INHIBITORY CONCENTRATION (MIC) = 4 MG/L, R. THE CUSTOMER'S STAPHYLOCOCCUS AUREUS STRAIN WAS CONFIRMED BY PCR MECC TO BE POSITIVE, CONFIRMING A (B)(6). THE CEFOXITIN DISK DIFFUSION RESULT FOR THE CUSTOMER'S STRAIN WAS RESISTANT. ANTIBIOTIC SUSCEPTIBILITY TESTING WAS PERFORMED USING THE VITEK 2 SYSTEM SOFTWARE VERSION V08.01, AND THE VITEK 2 AST-P580 CARD. THREE AST-P580 CARD LOTS (CUSTOMER LOTS, CL1: 3600850203, AND CL2: 3600816403) A RANDOM LOT (RL: 3600543403) WERE EACH TESTED. TRYPTICASE SOY AGAR WITH 5% SHEEP BLOOD WAS USED TO SUBCULTURE. THE OX RESULTS FOR THE CUSTOMER LOTS TESTED ON THE AST-P580 CARD YIELDED AN MIC = 0.5 MG/L, S CORRECTED TO *R ON BOTH CUSTOMER LOTS. THE OX RESULTS FOR THE RANDOM LOT TESTED ON THE AST-P580 CARD YIELDED AN MIC = 1 MG/L, S CORRECTED TO *R FOR THE RANDOM LOT. THE RESULTS CONFIRMED POSITIVE OXSF TESTS FOR EACH OF THE THREE LOTS OF P580 CARDS TESTED. THE POSITIVE OXSF TESTS CORRELATED WITH THE RESISTANT CEFOXITIN DISC DIFFUSION RESULTS (FOX KB R). THE OXSF AND OX TESTS RESULTS WORK TOGETHER TO ALLOW THE DETECTION OF THE (B)(6 PHENOTYPE. IN CONCLUSION, THE CUSTOMER'S POSITIVE OXSF RESULTS WERE REPRODUCED INTERNALLY. THOSE POSITIVE RESULTS ARE IN AGREEMENT WITH THE REFERENCE METHOD. THE VITEK 2 CARDS ARE PERFORMING AS EXPECTED.

    Description of Event or Problem · 1

    A CUSTOMER IN (B)(6) REPORTED FALSE POSITIVE CEFOXITIN SCREEN RESULTS FOR A STAPHYLOCOCCUS AUREUS PATIENT ISOLATE IN ASSOCIATION WITH THE VITEK® 2 AST-P580 TEST KIT (LOT 3600816403). THE CUSTOMER TESTED THE ISOLATE TWICE ON LOT 3600816403, AND THE RESULTS WERE CEFOXITIN SCREEN POSITIVE AND (B)(6). THE CUSTOMER TESTED THE ISOLATE ONCE ON ANOTHER LOT (3600850203) AND THE RESULT WAS ALSO CEFOXITIN SCREEN POSITIVE AND (B)(6). THE STRAIN WAS PBP2A NEGATIVE ((B)(6)). THE CUSTOMER REPORTED THAT NO WRONG RESULT WAS REPORTED TO THE CLINICIAN, AND THERE WAS NO IMPACT TO PATIENT TREATMENT. THERE WAS A DELAY GREATER THAN 24 HOURS BECAUSE OF RETESTING. 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
    1031260 VITEK® 2 AST-P580 TEST KIT VITEK® 2 AST-P580 TEST KIT LON BIOMERIEUX, INC. 3600816403

    Patients

    Seq Age Sex Outcome Treatment
    1