BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITEK 2 AST-GP75 TEST KIT

    MDR report key: 10514898 · Received September 10, 2020

    Report

    Report Number
    1950204-2020-00170
    Event Type
    Malfunction
    Date Received
    September 10, 2020
    Report Date
    November 22, 2020
    Manufacturer
    BIOMÉRIEUX, INC.
    Product Code
    LON
    UDI-DI
    03573026437183
    PMA / PMN Number
    K053097
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, 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 (RESISTANT) CEFOXITIN SCREEN (OXSF) FOR STAPHYLOCOCCUS AUREUS ATCC® 29213¿ WHILE PERFORMING INTERNAL QUALITY CONTROL TESTING WITH THE VITEK® 2 AST-GP75 TEST KIT (REF 415670, LOT 2751392103). AFTER TROUBLESHOOTING, THE ONSITE FIELD SERVICE ENGINEER (FSE) CHANGED THE OPTICS. THE CUSTOMER OBTAINED A NEW DISPENSETTE AND AUTOCLAVED THE ONE IN USE, AND THE ISSUE WAS RESOLVED. SINCE THE ISSUE WAS RESOLVED, THE CUSTOMER DID NOT SUBMIT THE STRAIN; THE INTERNAL QC STRAIN WAS TESTED INSTEAD FOR THE BIOMERIEUX INTERNAL INVESTIGATION. THE INTERNAL S. AUREUS ATCC 29213 STRAIN WAS SUBBED AND TESTED ON THE CUSTOMER¿S LOT AND A RANDOM LOT OF AST-GP75 CARDS (2751494403), IN DUPLICATE. ON ALL CARDS TESTED, THE EXPECTED NEGATIVE OXSF RESULTS WERE OBTAINED. ADDITIONALLY, NO OTHER QC DEVIATIONS OCCURRED ON ANY CARD TESTED. CARDS WERE PERFORMING AS EXPECTED FOR THIS QC STRAIN. THE CUSTOMERS ISSUE WAS NOT REPRODUCED. VITEK 2 AST-GP75 LOT 2751392103 MET FINAL QC RELEASE CRITERIA AND PASSED QC PERFORMANCE TESTING.SEE SECTION H10.

    Description of Event or Problem · 1

    A CUSTOMER IN THE UNITED STATES NOTIFIED BIOMÉRIEUX OF FALSE POSITIVE (RESISTANT) CEFOXITIN SCREEN RESULTS FOR STAPHYLOCOCCUS AUREUS ATCC® 29213¿ WHILE PERFORMING INTERNAL QUALITY CONTROL TESTING WITH THE VITEK® 2 AST-GP75 TEST KIT (REF 415670, LOT 2751392103). INITIAL AND REPEAT ANALYSIS OBTAINED POSITIVE (RESISTANT) CEFOXITIN SCREEN RESULTS. VITEK® 2: CEFOXITIN SCREEN = POSITIVE (RESISTANT). EXPECTED: CEFOXITIN SCREEN = NEGATIVE (SUSCEPTIBLE). TROUBLESHOOTING PERFORMED BY LOCAL CUSTOMER SERVICE (LCS) PROVIDED THE CUSTOMER WITH SOME SUGGESTIONS FOR IMPROVING THEIR SET UP, BUT THE CEFOXITIN SCREEN RESULTS OBTAINED WERE STILL POSITIVE (RESISTANT). A FIELD SERVICE ENGINEER (FSE) VISITED THE CUSTOMER'S SITE ON 20AUG2020 AND REPLACED THE OPTICS ON THE VITEK® 2 INSTRUMENT. THE CUSTOMER PERFORMED ADDITIONAL QUALITY CONTROL TESTING WITH LOT 2751392103 AFTER THE FSE REPLACED THE OPTICS AND OBTAINED FALSE POSITIVE CEFOXITIN SCREEN RESULTS. AS THIS DISCREPANCY OCCURRED DURING QUALITY CONTROL TESTING, THERE IS NO PATIENT INVOLVED. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    983069 VITEK 2 AST-GP75 TEST KIT VITEK® 2 AST-GP75 TEST KIT LON BIOMÉRIEUX, INC. 2751392103 03573026437183

    Patients

    Seq Age Sex Outcome Treatment
    1