BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITEK®2 AST-P631 TEST KIT

    MDR report key: 8297765 · Received February 1, 2019

    Report

    Report Number
    1950204-2019-00038
    Event Type
    Malfunction
    Date Received
    February 1, 2019
    Report Date
    April 2, 2019
    Manufacturer
    BIOMERIEUX, INC.
    Product Code
    LON
    PMA / PMN Number
    N50510: S117
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT WAS INITIALLY SUBMITTED IN RESPONSE TO A CUSTOMER REPORT REGARDING FALSE RESISTANT OXACILLIN (OX) RESULTS FOR STAPHYLOCOCCUS AUREUS IN ASSOCIATION WITH THE VITEK® 2 AST-P631 TEST KIT AND VERSION 8.01 SOFTWARE. BIOMÉRIEUX INVESTIGATION WAS CONDUCTED. THE ORGANISM ID WAS CONFIRMED TO STAPHYLOCOCCUS AUREUS VIA THE VITEK 2 GP ID CARD. AST TESTING CONSISTED OF THE FOLLOWING (REFERENCE AND DEVELOPMENT METHODS): · PCR MECA/MECC OBTAINED A RESULT OF "(B)(6)". (B)(6) STRAIN CONFIRMED. · KIRBY-BAUER CEFOXITIN (FOX KB), REFERENCE METHOD USED FOR CEFOXITIN SCREEN TEST DEVELOPMENT PROVIDED A SUSCEPTIBLE RESULT (D = 25.5MM). · AGAR DILUTION (AD), METHOD USED FOR OXACILLIN DEVELOPMENT (FORMULATION OX101N) ON AST-P631 CARD OBTAINED OX MIC = 0.25 MG/L (SUSCEPTIBLE). PRODUCT & SYSTEM INCRIMINATED VITEK 2 V8.01 AST-P631 CARD: · AES PARAMETERS: CASFM / EUCAST 2018_V1 · TEST OF THE CUSTOMER LOT (7310807403 CALLED CL) · TEST OF A RANDOM LOT (7310759103 CALLED RL) · THESE 2 LOTS WERE TESTED FROM CBA SUBCULTURE (COS BMX). OX MIC = 0.5 MG/L (SUSCEPTIBLE) ON BOTH LOTS TESTED. THESE OX VALUES ARE WITHIN ESSENTIAL AGREEMENT COMPARED TO THE REFERENCE AD MIC (0.5 S) WITHOUT ANY CATEGORY ERROR. NEGATIVE OXSF TESTS AND "ACQUIRED PENICILLINASE" PHENOTYPES GIVEN BY AES FOR BOTH LOTS TESTED. THE NEGATIVE OXSF TESTS ARE CORRELATED WITH THE DISC DIFFUSION RESULT (FOX KB S). THE INVESTIGATION CONCLUDED THAT THE CUSTOMER'S OXACILLIN RESISTANT RESULTS ON AST-P631 CARD ARE NOT REPRODUCED INTERNALLY.

    Description of Event or Problem · 1

    A CUSTOMER IN (B)(6) REPORTED A (B)(6) RESULT FOR A STAPHYLOCOCCUS AUREUS STRAIN FROM A PATIENT VAGINAL SAMPLE IN ASSOCIATION WITH THE VITEK®2 AST-P631 TEST KIT (LOT. #7310807403). THE CEFOXITIN SCREEN WAS NEGATIVE AND WAS MODIFIED BY AES TO POSITIVE, BECAUSE THE (B)(6)WAS (B)(6) INDICATING (B)(6). THE STRAIN WAS PBP2A NEGATIVE ((B)(6)). THE VITEK TEST WAS NOT REPEATED. 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
    90759 VITEK®2 AST-P631 TEST KIT VITEK®2 AST-P631 TEST KIT LON BIOMERIEUX, INC. 7310807403

    Patients

    Seq Age Sex Outcome Treatment
    1