BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITEK®2 AST-N297 TEST KIT

    MDR report key: 7327070 · Received March 9, 2018

    Report

    Report Number
    1950204-2018-00098
    Event Type
    Malfunction
    Date Received
    March 9, 2018
    Report Date
    June 13, 2018
    Manufacturer
    BIOMERIEUX INC.
    Product Code
    LON
    PMA / PMN Number
    K172944
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A CUSTOMER IN THE (B)(6) NOTIFIED BIOMÉRIEUX OF A FALSE SUSCEPTIBLE CEFTAZIDIME (CAZ) RESULT FOR ESCHERICHIA COLI NEQAS SURVEY SAMPLE ASSOCIATED WITH VITEK®2 AST-N297 TEST KIT (REFERENCE 415672). AN INVESTIGATION WAS PERFORMED. THE ORIGINAL STRAIN WAS TESTED FROM CBA (COS BMX) SUBCULTURE. THE REFERENCE METHODS (AGAR DILUTION, AD) WHICH WAS THE METHOD USED FOR CAZ DEVELOPMENT (FORMULATION CAZ01N) ON AST-N297 GAVE : CAZ MIC = 2 MG/L I (INTERPRETATION ACCORDING TO EUCAST GUIDELINES). THE REPRODUCIBILITY TESTING ON VT2 AST-N297 CARDS (CUSTOMER LOT 7170271403 AND RANDOM LOT 7170329203) GAVE RESULTS OF: CAZ MIC </= 1 MG/L S ON BOTH LOTS. FOR CAZ, THE NEQAS EXPECTED CATEGORY IS S OR I ,SO NO DISCREPANCY WAS OBSERVED. IN CONCLUSION, THE CUSTOMER SUSCEPTIBLE RESULTS WERE REPRODUCED AND ARE WITHIN ESSENTIAL AGREEMENT COMPARED TO THE REFERENCE AD MICS. THE VITEK 2 AST-N297 CARD PERFORMED AS INTENDED AND NO FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 1

    A CUSTOMER IN THE (B)(6) NOTIFIED BIOMERIEUX OF A FALSE SUSCEPTIBLE RESULT ASSOCIATED WITH VITEK®2 AST-N297 TEST KIT (REFERENCE 415672). THE CUSTOMER REPORTED THE ORGANISM WAS ESCHERICHIA COLI AND THE ANTIBIOTIC IN QUESTION WAS CEFTAZIDIME. (B)(6) REPORTED THE ORGANISM AS S TO CEFTAZIDIME ON THE BASIS OF A CEFTAZIDIME MIC = <= 1 MG/L. THE NEQAS SCHEME ORGANIZERS ISSUED THE FINAL RESULT FOR THE ORGANISM AS I TO CEFTAZIDIME WITH A STATED MIC = 4 MG/L. UPON REPEAT TESTING USING ALL THREE (3) VITEK®2 INSTRUMENTS, VITEK® 2039, 3006 AND VITEK® 2036 ACHIEVED MIC = <= 1 (S). THIS RESULT WAS NOT SCORED BUT ATTENTION WAS DRAWN TO THE POOR PERFORMANCE OF AUTOMATED SYSTEMS WITH ONLY 3.4% REPORTING A CORRECT MIC. ALL TWENTY (20) (B)(6) LABORATORIES REPORTED CEFTAZIDIME AS S. THERE IS NO PATIENT ASSOCIATED WITH THIS CASE. AN INTERNAL BIOMÉRIEUX INVESTIGATION WILL BE INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171270 VITEK®2 AST-N297 TEST KIT VITEK®2 AST-N297 TEST KIT LON BIOMERIEUX INC. 7170271403

    Patients

    Seq Age Sex Outcome Treatment
    1