BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITEK® 2 AST-GN70 TEST KIT

    MDR report key: 7914595 · Received September 27, 2018

    Report

    Report Number
    1950204-2018-00395
    Event Type
    Malfunction
    Date Received
    September 27, 2018
    Report Date
    December 7, 2018
    Manufacturer
    BIOMERIEUX, INC.
    Product Code
    LON
    UDI-DI
    03573026398477
    PMA / PMN Number
    N50510: S 97
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    510K NUMBER UPDATED TO N50510: S97.

    Additional Manufacturer Narrative · 1

    AN INTERNAL BIOMÉRIEUX INVESTIGATION WAS INITIATED DUE TO FALSE RESULTS ASSOCIATED WITH THE VITEK® 2 AST-GN70 CARD WHEN TESTING API SURVEY STRAIN UR-06 ESCHERICHIA COLI. AMPICILLIN/SULBACTAM (AMS) AND CEFEPIME (FEP) WERE REPORTED AS SUSCEPTIBLE. THE EXPECTED RESULT FOR THESE DRUGS WAS RESISTANT. THE STRAIN WAS SUBMITTED FOR INVESTIGATION. THE SUBMITTED STRAIN WAS SUBCULTURED, AND THE IDENTIFICATION WAS CONFIRMED AS E. COLI. TESTING WAS PERFORMED ON VITEK 2 AST-GN70 CARDS FROM THE CUSTOMER LOTS (5900727403, 5900755403) AND A RANDOM LOT (5900650403), AS WELL AS AGAR DILUTION (AD) AS THE REFERENCE METHOD FOR FEP02N AND SAM01N FORMULATIONS FOUND ON THIS CARD. CLSI BREAKPOINTS: AMS </= 8 (S) 16 (I) >/= 32 (R) FEP </= 2 (S) 4-8 (SDD) >/=16 (R) AMPICILLIN/SULBACTAM MICS = 8 (S), 4 (S), >/=32 (R) ON THE THREE(3) VITEK 2 GN70 CARDS TESTED. AMS AD MIC =32 (R). CARDS AND REFERENCE METHOD ARE IN AGREEMENT FOR ONE (1) CARD, AND ESSENTIAL AGREEMENT ERROR FOR THE OTHER TWO (2) CARDS, DEMONSTRATING A VERY MAJOR ERROR FOR THE VITEK 2. CEFEPIME MICS </=1* ON TWO CARDS MIC = 2* ON THE REMAINING CARD, ALL WITH AES SOFTWARE MODIFICATION TO RESISTANT DUE TO A PROPOSED ESBL PHENOTYPE. FEP AD MIC = 8, DEMONSTRATING AS ESSENTIAL AGREEMENT ERROR BETWEEN VITEK 2 AND REFERENCE METHOD. CONCLUSION: ATYPICAL SURVEY STRAIN A COMPLAINT AND QUALITY REVIEW WAS PERFORMED, WHICH DID NOT IDENTIFY THIS DISCREPANCY AS A SYSTEMIC QUALITY ISSUE.

    Description of Event or Problem · 1

    A CUSTOMER IN THE UNITED STATES NOTIFIED BIOMÉRIEUX OF DISCREPANT RESULTS ASSOCIATED WITH VITEK® 2 AST-GN70 TEST KIT (REFERENCE 413401). THE CUSTOMER REPORTED RECEIVING AN INCORRECT RESULT ON THE API SURVEY. ON AN ESCHERICHIA COLI ISOLATE, AMPICILLIN/SULBACTAM AND CEFEPIME WERE REPORTED AS SENSITIVE. THE EXPECTED RESULTS FOR THESE DRUGS WERE INTERMEDIATE OR RESISTANT. THERE WAS NO PATIENT INVOLVED IN THIS EVENT. AN INTERNAL BIOMÉRIEUX INVESTIGATION WILL BE INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    756738 VITEK® 2 AST-GN70 TEST KIT VITEK® 2 AST-GN70 TEST KIT LON BIOMERIEUX, INC. 5900755403 03573026398477

    Patients

    Seq Age Sex Outcome Treatment
    1