BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITEK® 2 AST-P619 TEST KIT

    MDR report key: 7862122 · Received September 10, 2018

    Report

    Report Number
    1950204-2018-00349
    Event Type
    Malfunction
    Date Received
    September 10, 2018
    Report Date
    December 10, 2018
    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 INITIATED DUE TO FALSE POSITIVE CEFOXITIN SCREEN RESULTS FOR TWO (2) STAPHYLOCOCCUS AUREUS STRAINS FROM TWO (2) PATIENTS IN ASSOCIATION WITH THE VITEK® 2 AST-P619 CARD (LOT 4990676403 AND VITEK 2 SOFTWARE VERSION 7.01). THE CUSTOMER STATED THAT THE TEST RESULTS FOR BOTH PATIENT ISOLATES ON THE VITEK 2 AST-P619 CARD WERE A FALSE POSITIVE CEFOXITIN SCREEN TEST AND A SUSCEPTIBLE OXACILLIN (OXA) (MIC= 0.25 MG/L). BOTH ISOLATES WERE ALSO TESTED ON MHA-OXA PLATES, AND NO GROWTH WAS OBSERVED. PCR MECA AND MECC WERE NEGATIVE, AND THE STRAINS WERE CONFIRMED AS MSSA STRAINS. THE CUSTOMER REPEATED THE TESTING AND OBTAINED THE APPROPRIATE SUSCEPTIBLE RESULTS. THE CUSTOMER IS NOT ABLE TO PROVIDE THE STRAINS, REPEAT LAB REPORTS OR RAW CARD DATA. SUBMITTAL OF THE ISOLATE IS REQUIRED IN ORDER TO CONFIRM A VITEK 2 DISCREPANCY COMPARED TO REFERENCE. VITEK 2 RAW DATA IS HELPFUL IN THE ASSESSMENT OF ORGANISM GROWTH IN THE VITEK 2 CARD WHEN INITIAL AND REPEAT RESULTS DIFFER. VITEK 2 AST-P619 (LOT # 4990676403) MET FINAL QC RELEASE CRITERIA AND PASSED QC PERFORMANCE TESTING.

    Description of Event or Problem · 1

    A CUSTOMER IN (B)(6) REPORTED FALSE POSITIVE CEFOXITIN SCREEN RESULTS FOR TWO (B)(6) STRAINS FROM TWO (2) PATIENTS IN ASSOCIATION WITH THE VITEK® 2 AST-P619 TEST KIT (LOT 4990676403 AND VITEK 2 SOFTWARE VERSION 7.01. THE CUSTOMER REPORTED CULTURES WERE INCUBATED FOR 18-24 HOURS AT 36°C WITH CO2. COS MEDIA WAS USED FOR SUBCULTURE. THE CUSTOMER STATED THAT THE TEST RESULTS FOR BOTH PATIENT ISOLATES ON THE AST-P619 CARD, WERE A FALSE POSITIVE CEFOXITIN SCREEN TEST, AND A (B)(6). BOTH ISOLATES WERE ALSO TESTED ON MHA-OXA PLATES AND NO GROWTH WAS OBSERVED. (B)(6) WERE (B)(6), AND THE STRAINS WERE CONFIRMED AS (B)(6) STRAINS. NO PATIENT INFORMATION WAS PROVIDED BY THE CUSTOMER. THE CUSTOMER STATED THERE WAS A DELAY GREATER THAN 24 HOURS TO REPORT RESULTS. 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
    703205 VITEK® 2 AST-P619 TEST KIT VITEK® 2 AST-P619 TEST KIT LON BIOMERIEUX, INC. 4990676403

    Patients

    Seq Age Sex Outcome Treatment
    1