BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITEK® 2 AST-N351

    MDR report key: 8074335 · Received November 15, 2018

    Report

    Report Number
    1950204-2018-00514
    Event Type
    Malfunction
    Date Received
    November 15, 2018
    Report Date
    April 1, 2019
    Manufacturer
    BIOMERIEUX, INC.
    Product Code
    LON
    PMA / PMN Number
    N50510: S103
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION WAS PERFORMED IN RESPONSE TO CUSTOMER COMPLAINTS REPORTING AN INCREASE IN THE FREQUENCY OF ESBL PHENOTYPE DETECTION BY THE ADVANCED EXPERT SYSTEM (AES) FOLLOWING THE UPDATE TO VITEK 2 SYSTEMS (V2S) SOFTWARE VERSION 8.01. TESTING BY ALTERNATE METHODS HAS NOT CONFIRMED THE PRESENCE OF ESBL IN IMPACTED STRAINS. CONCLUSION: IN THE AES VERSION 8.01 OF THE VITEK2 SOFTWARE, THE MIC RANGES FOR E. COLI AND PIPERACILLIN/TAZOBACTAM WERE CHANGED FOR THE 'ACQUIRED PENICILLINASE' AND 'INHIBITOR RESISTANT PENICILLINASE' PHENOTYPES. THESE CHANGES CONSISTED IN REMOVING MICS >=128 MG/L AS POSSIBLE MICS FOR BOTH PHENOTYPES. THE CONSEQUENCE IS THAT THIS CHANGE HAS REVEALED A PREEXISTING ISSUE IN THE AES DEFINITION OF THE CEFUROXIME MIC RANGE FOR E. COLI AND ESBLS (CEFUROXIME MICS <=8 MG/L SHOULD PREVENT THE ESBL PROPOSAL). THIS, IN ADDITION TO THE SPECIFIC ANTIBIOTIC CONFIGURATION OF THE AST-N351 CARD AND ABSENCE OF THE ESBL TEST, IS THE ROOT CAUSE OF THE REPORTED INCREASE IN ESBL PHENOTYPE PROPOSAL FOR THE AST-N351 CARD. THIS ISSUE WILL BE CORRECTED IN VITEK 2 SYSTEMS SOFTWARE VERSION 9.02. IT SHOULD BE NOTED THAT THERE ARE NO PUBLISHED PERFORMANCE CLAIMS FOR PHENOTYPE DETECTION BY AES. A FIELD SAFETY CORRECTIVE ACTION (FSCA 4191-1) WAS ISSUED 13-DEC-2018 TO THE (B)(6) 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. PMA/510(K) NUMBER CORRECTED TO N50510: S103.

    Description of Event or Problem · 1

    A CUSTOMER FROM THE (B)(6) NOTIFIED BIOMÉRIEUX OF FALSE POSITIVE DETECTION OF ESBL PHENOTYPE WHEN TESTING ESCHERICHIA COLI WITH THE VITEK® 2 AST-N351 TEST KIT (REF 421257, LOT 7910693403). ISOLATE (B)(6). ESBL PHENOTYPE WAS PROPOSED. MANUAL ESBL DISCS WERE NEGATIVE. THE CUSTOMER REPORTED THAT NO WRONG RESULT WAS REPORTED TO A PHYSICIAN, AND THAT NO PATIENT WAS HARMED OR TREATED INCORRECTLY. THE CUSTOMER REPORTED A DELAY OF ONE DAY (24 HOURS) IN REPORTING RESULTS. AN INTERNAL BIOMÉRIEUX INVESTIGATION WILL BE INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    914934 VITEK® 2 AST-N351 VITEK® 2 AST-N351 LON BIOMERIEUX, INC. 7910693403

    Patients

    Seq Age Sex Outcome Treatment
    1