BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITEK® 2 AST-N351 TEST KIT

    MDR report key: 8065128 · Received November 13, 2018

    Report

    Report Number
    1950204-2018-00509
    Event Type
    Malfunction
    Date Received
    November 13, 2018
    Report Date
    March 19, 2019
    Manufacturer
    BIOMERIEUX, INC.
    Product Code
    LON
    PMA / PMN Number
    N50510: S103
    Removal / Correction Number
    4191-1
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AN INTERNAL INVESTIGATION WAS PERFORMED FOR A FALSE POSITIVE ESBL (EXTENDED SPECTRUM BETA-LACTAMASE) PHENOTYPE FOR AN ESCHERICHIA COLI ISOLATE IN ASSOCIATION WITH THE VITEK® 2 AST-N351 TEST KIT. THE CUSTOMER'S SUBMITTED STRAIN WAS CONFIRMED TO ESCHERICHIA COLI WITH THE VITEK 2 GN ID CARD. THE PRESENCE OF THE ESBL WAS CHECKED WITH THE REFERENCE ESBL SCREENING TESTS (USING COMBINED DISCS AND THE KEY HOLE TEST) : NEGATIVE ESBL RESULT. THIS STRAIN IS NOT AN ESBL PRODUCING BACTERIA. TESTING INCLUDING ONE AST-N351 CARD FROM THE CUSTOMER LOT (CL: 7910638103) AND A RANDOM LOT (RL: 7910579403) WITH VT2 SOFTWARE VERSION V8.01 (CBA AND MCK MEDIA), AS WELL AS ONE EXTENDED CARD AST-N233 + AST-XN05. ON THE AST-N351 CARD, THE CUSTOMER RESULT WAS NOT REPRODUCED IN-HOUSE (FALSE "EXTENDED SPECTRUM BETA-LACTAMASE" PHENOTYPE) . AES GAVE "INHIBITOR RESISTANT PENICILLINASE (IRT OR OXA) , ACQUIRED PASE" PHENOTYPE ON BOTH LOTS AND FROM BOTH MEDIA TESTED. THE CUSTOMER'S FALSE ESBL PHENOTYPE WAS NOT REPRODUCED IN-HOUSE. A SEARCH FOR ALL COMPLAINTS AGAINST AST-N351 CARD LOT 7910638103 DID NOT INDICATE A LOT SPECIFIC ISSUE. A REVIEW OF THE MOST RECENT QUARTERLY TREND REPORT, Q2 2018, DID NOT IDENTIFY THIS COMPLAINT AS A SYSTEMIC QUALITY ISSUE. A FIELD SAFETY CORRECTIVE ACTION (FSCA 4191-1) WAS ISSUED 13-DEC-2018 TO THE UNITED KINGDOM TO ADDRESSES THIS ISSUE IN THE FIELD. THE ASSOCIATED URGENT PRODUCT CORRECTION NOTICE INFORMS CUSTOMERS OF THE ESBL PHENOTYPE PROPOSAL AND DESCRIBES CRITERIA LIMITATIONS TO BE APPLIED VIA A VITEK® 2 BIOART RULE. THE BIOART RULE WILL PREVENT INAPPROPRIATE PROPOSAL OF THE ESBL PHENOTYPE. CORRECTED DATA: SECTION G.5 PMA/510(K) NUMBER CORRECTED TO N50510: S103.

    Description of Event or Problem · 1

    A CUSTOMER IN (B)(6) REPORTED A FALSE POSITIVE ESBL (EXTENDED SPECTRUM BETA-LACTAMASE) PHENOTYPE FOR AN ESCHERICHIA COLI ISOLATE IN ASSOCIATION WITH THE VITEK® 2 AST-N351 TEST KIT. A PATIENT ISOLATE WAS TESTED WITH DISC DIFFUSION AND THE CEPHALOSPORINS TESTED ALL SUSCEPTIBLE. THE ISOLATE WAS THEN TESTED WITH THE AST-N351 CARD AND THE VITEK AES SOFTWARE MODIFIED ALL SUSCEPTIBLE CEPHALOSPORINS TO RESISTANT, AND WAS FLAGGED AS AN ESBL PHENOTYPE. THE CUSTOMER REPORTED THE ESBL WAS CHECKED AND WAS NEGATIVE BY DISC CONFIRMATION. 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
    907546 VITEK® 2 AST-N351 TEST KIT VITEK® 2 AST-N351 TEST KIT LON BIOMERIEUX, INC. 7910638103

    Patients

    Seq Age Sex Outcome Treatment
    1