BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITEK 2 AST-GP75 TEST KIT

    MDR report key: 11113377 · Received January 4, 2021

    Report

    Report Number
    1950204-2021-00001
    Event Type
    Malfunction
    Date Received
    January 4, 2021
    Report Date
    January 26, 2021
    Manufacturer
    BIOMÉRIEUX, INC
    Product Code
    LON
    UDI-DI
    03573026437183
    PMA / PMN Number
    K053097
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT WAS INITIALLY SUBMITTED FOLLOWING NOTIFICATION FROM A CUSTOMER IN THE UNITED STATES REGARDING FALSE POSITIVE CEFOXITIN SCREEN (OXSF) TEST FOR S. AUREUS ATCC® 29213¿ STRAIN IN ASSOCIATION WITH VITEK® 2 AST-GP75 TEST KIT 20 CARDS ¿ (REF. (B)(4), LOT 2751438113. NO LAB REPORTS, TROUBLESHOOTING INFORMATION, NOR THE STRAIN WAS AVAILABLE FOR INVESTIGATION EVALUATION. INTERNAL TESTING WAS CONDUCTED USING CARDS FROM THE CUSTOMER'S LOT AND A RANDOM LOT OF AST-GP75 CARDS, 2751494403, IN DUPLICATE. TESTING WAS CONDUCTED USING THE INTERNAL BIOMÉRIEUX STAPHYLOCOCCUS AUREUS ATCC STRAIN 29213 (694). TESTING ON ALL OF THE CARDS RESULTED IN THE EXPECTED NEGATIVE OXSF RESULTS. THE CUSTOMER'S FALSE POSITIVE OXSF RESULT WAS NOT REPRODUCED WHEN TESTING FROM THE BIOMÉRIEUX INTERNAL QC STRAIN. VITEK® 2 AST-GP75 LOT 2751438113 MET FINAL QC RELEASE CRITERIA. IN ADDITION, THE CUSTOMER HAD THEIR READER OPTICS REPLACED BY A FIELD SERVICE ENGINEER (FSE), AND HAS EXPERIENCED NO ADDITIONAL ISSUES.SEE SECTION H10.

    Description of Event or Problem · 1

    A CUSTOMER IN THE UNITED STATES NOTIFIED BIOMÉRIEUX OF A QUALITY CONTROL FAILURE, FALSE POSITIVE CEFOXITIN SCREEN TEST FOR S. AUREUS ATCC® 29213¿ STRAIN IN ASSOCIATION WITH VITEK® 2 AST-GP75 TEST KIT 20 CARDS ¿ (REF. 415670), LOT. #2751438113. THE EXPECTED RESULT IS CEFOXITIN SCREEN NEGATIVE. IT SHOULD BE NOTED THAT THIS CUSTOMER ALREADY REPORTED THE SAME QC FAILURE FOR THIS ATCC STRAIN USING A DIFFERENT LOT. GCS (GLOBAL CUSTOMER SERVICE) SUGGESTED TO THE CUSTOMER TO REPEAT TESTING WITH THE FOLLOWING RECOMMENDATIONS: CLEAN THE OPTICS OF THE INSTRUMENT. OBTAIN A NEW CULTILOOP. STREAK TO SBA AND INCUBATE IN 35 DEGREES CELSIUS IN CO2. CHECK FOR PURITY. REPEAT STREAK TO SBA FOR 24 HOURS. PLACE ON THE INSTRUMENT. REPEAT TESTING FOLLOWING THOSE RECOMMENDATIONS STILL RESULTED IN QC FAILURE. THEREFORE, THE OPTICS WERE CHANGED AT THE CUSTOMER SITE AND SINCE THIS REPLACEMENT, THE CUSTOMER DOES NOT ENCOUNTER THE ISSUE ANYMORE. THERE IS NO PATIENT ASSOCIATED WITH THIS QC ISOLATE; THEREFORE, THERE IS NO ADVERSE EVENT RELATED TO ANY PATIENT'S STATE OF HEALTH. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    5469 VITEK 2 AST-GP75 TEST KIT VITEK® 2 AST-GP75 TEST KIT LON BIOMÉRIEUX, INC 2751438113 03573026437183

    Patients

    Seq Age Sex Outcome Treatment
    1