BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITEK® 2 AST-N334 TEST KIT

    MDR report key: 7861307 · Received September 10, 2018

    Report

    Report Number
    1950204-2018-00344
    Event Type
    Malfunction
    Date Received
    September 10, 2018
    Report Date
    November 13, 2018
    Manufacturer
    BIOMERIEUX, INC.
    Product Code
    LON
    PMA / PMN Number
    K161227
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A CUSTOMER FROM (B)(6) SUBMITTED FIVE ESCHERICHIA COLI STRAINS FOR CEFEPIME (FEP) EVALUATION BECAUSE TWO LOTS OF AST-GN09 CARDS AND ONE LOT OF AST-N334 CARDS GAVE SUSCEPTIBLE RESULTS FOR THESE STRAINS. KIRBY-BAUER AND BROTH MICRODILUTION GAVE RESISTANT RESULTS. IDENTIFICATION OF THE ISOLATES WAS CONFIRMED, AND TESTING INCLUDED THE CUSTOMER LOT OF AST-N334 CARDS AND A RANDOM LOT OF AST-N334 CARDS. BROTH MICRODILUTION (BMD), THE REFERENCE METHOD FOR FEP03N, WHICH IS THE FEP FORMULATION FOUND ON THE AST-N334 CARD WAS ALSO PERFORMED. CLSI BREAKPOINTS: <=8 S, 16 I, >=32 R. FOR ISOLATE 911689: BOTH AST-N334 CARDS GAVE MICS=2, BUT BMD GAVE AN MIC=8. THIS IS AN ESSENTIAL AGREEMENT ERROR FOR THE VITEK 2. IN SUMMARY: THE STRAIN IS ATYPICAL AND EXHIBITED AN ESSENTIAL AGREEMENT ERROR BETWEEN THE CARD AND REFERENCE METHOD RESULTS (MORE THAN ONE DOUBLING DILUTION APART FOR BOTH AST-N334 CARD LOTS TESTED).

    Description of Event or Problem · 1

    A CUSTOMER IN (B)(6) REPORTED FALSE SUSCEPTIBLE CEFEPIME RESULTS FOR ESCHERICHIA COLI STRAINS FROM FIVE (5) PATIENTS, IN ASSOCIATION WITH THE VITEK® 2 AST-GN09 TEST KIT. THE CUSTOMER REPORTED THAT THE AST-GN09 CARD GAVE A CEFEPIME FALSE SUSCEPTIBLE RESULT TWICE, AND THE KIRBY-BAUER DISK TEST WAS RESISTANT. THE FIVE (5) PATIENT STRAINS WERE FROM DIFFERENT SOURCES (BLOOD, URINE, SPUTUM, URINE, CSF). THESE STRAINS WERE THEN SENT TO (B)(4) BIOMÉRIEUX AND FURTHER TESTING WAS PERFORMED. THE FIVE (5) STRAINS WERE TESTED USING THE VITEK 2 AST-GN09 ((B)(4)) AND AST-N334 ((B)(4)), LOT 7740750403 CARDS, ATB (BIOMÉRIEUX REAGENTS), AND BROTH MICRODILUTION (BMD). THE RESULTS FOR AST-GN09, AST-N334 LOT 7740750403, AND ATB WERE SUSCEPTIBLE WHEN COMPARED TO BMD WHICH WAS RESISTANT. THE CUSTOMER STATED THERE WAS NO IMPACT TO THE PATIENTS. IT IS NOT KNOWN WHICH RESULTS WERE REPORTED TO A PHYSICIAN. 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
    703408 VITEK® 2 AST-N334 TEST KIT VITEK® 2 AST-N334 TEST KIT LON BIOMERIEUX, INC. 7740750403

    Patients

    Seq Age Sex Outcome Treatment
    1