BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITEK 2 AST-GP67 TEST KIT

    MDR report key: 10932707 · Received December 2, 2020

    Report

    Report Number
    1950204-2020-00208
    Event Type
    Malfunction
    Date Received
    December 2, 2020
    Report Date
    January 26, 2021
    Manufacturer
    BIOMÉRIEUX, INC
    Product Code
    LON
    UDI-DI
    03573026242060
    PMA / PMN Number
    K053097
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT WAS INITIALLY SUBMITTED FOLLOWING NOTIFICATION FROM A CUSTOMER IN THE UNITED STATES REGARDING A FALSE POSITIVE RESULT FOR CEFOXITIN SCREEN WHILE TESTING A STAPHYLOCOCCUS AUREUS ATCC® 29213¿ QC STRAIN USING THE VITEK® 2 AST-GP67 TEST KIT (REFERENCE # 22226, LOT # 1321529403). A FIELD SERVICE ENGINEER (FSE) WENT TO THE CUSTOMER SITE AND REPLACED THE B SIDE OPTICS. THE CUSTOMER HAS HAD NO ADDITIONAL ISSUES SINCE THE OPTICS WERE REPLACED. VITEK® 2 AST-GP67 LOT 1321529403 MET FINAL QC RELEASE CRITERIA AND PASSED QC PERFORMANCE TESTING. SINCE THE CUSTOMER HAD EXPERIENCED NO FURTHER ISSUES AFTER THE FSE VISIT, DUE TO TIME CONSTRAINTS, THEY DECLINED TO PROVIDE FURTHER INFORMATION (PATIENT STRAIN, LAB REPORTS, TROUBLESHOOTING INFORMATION). NO FURTHER INVESTIGATION IS POSSIBLE.

    Description of Event or Problem · 1

    A CUSTOMER IN THE UNITED STATES NOTIFIED BIOM¿RIEUX OF OBTAINING A FALSE POSITIVE RESULT FOR CEFOXITIN SCREEN WHILE TESTING A (B)(6) ATCC¿ 29213" QC STRAIN USING THE VITEK¿ 2 AST-GP67 TEST KIT (REFERENCE #: (B)(4), LOT #: 1321529403). THE CUSTOMER STATED THEY DO NOT REPEAT VITEK 2 RESULTS IF THEY GET A FALSE POSITIVE CEFOXITIN SCREEN. INSTEAD THEY CONFIRM RESULTS USING PCR AS AN ALTERNATIVE TESTING METHOD. A FIELD SERVICE ENGINEER (FSE) WENT TO THE CUSTOMER SITE ON 15NOV2020, AND REPLACED THE B SIDE OPTICS. THE CUSTOMER HAS HAD NO ISSUES SINCE THE OPTICS WERE REPLACED. SINCE THE CUSTOMER IS NO LONGER HAVING ISSUES THEY HAVE DECLINED TO PROVIDE FURTHER INFORMATION AT THIS TIME DUE TO TIME-CONSTRAINTS. THERE IS NO PATIENT ASSOCIATED WITH THIS QC ISOLATE; THEREFORE, THERE IS NO ADVERSE EVENT RELATED TO ANY PATIENT'S STATE OF HEALTH. A BIOM¿RIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1399012 VITEK 2 AST-GP67 TEST KIT VITEK® 2 AST-GP67 TEST KIT LON BIOMÉRIEUX, INC 1321529403 03573026242060

    Patients

    Seq Age Sex Outcome Treatment
    1