BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITEK® 2 AST-ST01 TEST KIT

    MDR report key: 5090850 · Received September 21, 2015

    Report

    Report Number
    1950204-2015-00041
    Event Type
    Malfunction
    Date Received
    September 21, 2015
    Report Date
    September 18, 2015
    Manufacturer
    BIOMERIEUX, INC
    Product Code
    LON
    PMA / PMN Number
    K112228
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED TO MANUFACTURER.

    Additional Manufacturer Narrative · 1

    BIOMÉRIEUX INVESTIGATION WAS CONDUCTED. TESTING INCLUDED: TWO (2) VITEK® 2 AST-ST01 CARDS OF THE LOT IN USE BY THE CUSTOMER (540367040) AND TWO (2) CARDS OF A RANDOM LOT (540362720) WITH THE CUSTOMER STRAIN STREPTOCOCCUS PNEUMONIAE ATCC 49619 AND WITH THE INTERNAL REFERENCE STRAIN (FROZEN STOCK R&D LBM) SUBCULTURED ON TSAB AND PVX MEDIUM. TESTING RESULTS (CUSTOMER STRAIN): OBTAINED THE EXPECTED RESULT OF LEVOFLOXACIN MIC = 0.5 MG/L. THE CUSTOMER'S OUT-OF-RANGE-LOW RESULT WAS NOT REPRODUCED. TESTING RESULTS (INTERNAL REFERENCE STRAIN): OBTAINED LEVOFLOXACIN MIC = 0.5 MG/L. THE CUSTOMER'S OUT-OF-RANGE-LOW RESULT WAS NOT REPRODUCED. THE VITEK® 2 AST-ST01 TEST KIT PRODUCT IS PERFORMING AS INTENDED WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    A CUSTOMER IN (B)(6) REPORTED A QC FAILURE WITH ATCC 49619 FOR LEVOFLOXACIN WHEN TESTED WITH THE VITEK 2 AST-ST01 TEST KIT. THE LEVOFLOXACIN MIC WAS 0.25 WHEN THE EXPECTED RESULT WAS 0.5 - 2. THOUGH THE LABORATORY REPORTED RESULTS FOR LEVOFLOXACIN IN SPITE OF THE QC DEVIATION, THE CUSTOMER INDICATES THERE HAS BEEN NO INCORRECT TREATMENT OR DETERIORATION IN PATIENT STATE OF HEALTH DUE TO THE DISCREPANT QC RESULT. THERE IS NO INDICATION OF DELAY IN REPORTING OF RESULTS OR DELAY IN PATIENT TREATMENT. THERE MAY BE A POTENTIAL FOR ADVERSE EVENT IF THE EVENT WERE TO REOCCUR; THEREFORE THIS EVENT IS BEING REPORTED AS A MALFUNCTION. CULTURE SUBMITTALS HAVE BEEN REQUESTED BY BIOMERIEUX. AN INTERNAL BIOMERIEUX INVESTIGATION WILL BE INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    622315 VITEK® 2 AST-ST01 TEST KIT VITEK® 2 AST-ST01 CARD LON BIOMERIEUX, INC 540367040

    Patients

    Seq Age Sex Outcome Treatment
    1