BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITEK® 2 AST-GP67 TEST KIT

    MDR report key: 7926604 · Received October 2, 2018

    Report

    Report Number
    1950204-2018-00404
    Event Type
    Malfunction
    Date Received
    October 2, 2018
    Report Date
    December 26, 2018
    Manufacturer
    BIOMERIEUX, INC.
    Product Code
    LON
    UDI-DI
    03573026242060
    PMA / PMN Number
    K053097
    Removal / Correction Number
    FSCA 4018
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AN INTERNAL BIOMÉRIEUX INVESTIGATION WAS INITIATED DUE TO A FALSE NEGATIVE CEFOXITIN SCREEN TEST (OXSF) RESULT FOR A STAPHYLOCOCCUS AUREUS STRAIN FROM A PATIENT ISOLATE IN ASSOCIATION WITH THE VITEK® 2 AST-GP67 CARD AND SOFTWARE VERSION 7.01. NOTE: THE CUSTOMER'S RESULTS TRIGGERED THE BIOART RULE AS DESCRIBED IN FSCA 4018 ISSUED FOR THE US, 21AUG2018, ALERTING THE USER WITH FURTHER INSTRUCTION PER THEIR LABORATORY PRACTICES. THE SUBMITTED STRAIN WAS SUBCULTURED TO TSAB AGAR, IDENTIFICATION CONFIRMED AS S. AUREUS, AND TESTING INCLUDED VITEK 2 AST-GP67 CARDS FROM THE CUSTOMER'S LOT (1320774203) AND A RANDOM LOT (1320467103) WITH VITEK 2 SOFTWARE VERSIONS 7.01 AND 8.01, AS WELL AS AGAR DILUTION (AD) AS THE REFERENCE METHOD FOR OXACILLIN (OX), CEFOXITIN DISK DIFFUSION AS THE REFERENCE METHOD FOR CEFOXITIN SCREEN TEST (OXSF) TEST AND PBP2A. 911784 (B24099): BOTH VITEK 2 AST-GP67 CARDS TESTED WITH V7.01 RESULTED IN NEGATIVE OXSF TESTS AND MICS =2. BOTH VITEK 2 AST-GP67 CARDS TESTED WITH V8.01 RESULTED IN POSITIVE OXSF TESTS AND MICS = 1 AND 2 WITH AES PROPOSED MODIFICATIONS TO RESISTANT. PBP2A WAS POSITIVE FOR MECA AND OX AD MIC = 1. CEFOXITIN DISK DIFFUSION WAS RESISTANT (16 MM) WITH SMALL COLONIES OBSERVED IN THE ZONE OF INHIBITION. VITEK 2 AST-GP67 TESTING WAS PERFORMED ON THESE CEFOXITIN INDUCED COLONIES RESULTING IN POSITIVE OXSF TESTS, RESISTANT OX MICS <= 4 AND DETECTION OF MRSA WITH VITEK 2 SOFTWARE VERSIONS 7.01 AND 8.01 SUGGESTING THE PRESENCE OF A HETEROGENEOUS STRAIN. IT IS IMPORTANT TO KEEP IN MIND THAT THE OXACILLIN AND CEFOXITIN SCREEN TESTS WORK TOGETHER TO DETERMINE THE FINAL OXACILLIN STATUS. FOR S. AUREUS, IF EITHER OXACILLIN IS R, OR CEFOXITIN SCREEN IS POSITIVE, THE OXACILLIN INTERPRETATION IS R. OXACILLIN MIC TESTING ALONE IS NOT ALWAYS ADEQUATE TO DETECT RESISTANCE. THEREFORE, THE CEFOXITIN SCREEN TEST IS USED IN CONJUNCTION WITH OXACILLIN, IN ORDER TO HAVE OPTIMAL METHICILLIN RESISTANCE DETECTION.

    Description of Event or Problem · 1

    A CUSTOMER IN THE UNITED STATES REPORTED A (B)(6) RESULT FOR A (B)(6) STRAIN FROM A PATIENT ISOLATE IN ASSOCIATION WITH THE VITEK® 2 AST-GP67 TEST KIT (LOT 1320774203). THE CUSTOMER REPORTED THAT THE INITIAL TEST WAS (B)(6). THE REPEAT TEST RESULT WAS (B)(6). THE CUSTOMER PERFORMED (B)(6) DISC DIFFUSION AND THE RESULT WAS (B)(6) (17MM). THE CUSTOMER STATED THAT THE PATIENT WAS TREATED WITH AN ANTIBIOTIC AND THERE WAS NO INCORRECT TREATMENT . 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. BIOMÉRIEUX ADVISED THE CUSTOMER TO PERFORM (B)(6) TESTING, OR THE (B)(6) TESTING FOR CONFIRMATION. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    766918 VITEK® 2 AST-GP67 TEST KIT VITEK® 2 AST-GP67 TEST KIT LON BIOMERIEUX, INC. 1320774203 03573026242060

    Patients

    Seq Age Sex Outcome Treatment
    1