BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITEK® 2 AST-GP67 TEST KIT

    MDR report key: 6118500 · Received November 21, 2016

    Report

    Report Number
    1950204-2016-00188
    Event Type
    Injury
    Date Received
    November 21, 2016
    Report Date
    October 27, 2016
    Manufacturer
    BIOMERIEUX, INC.
    Product Code
    LON
    PMA / PMN Number
    K072668
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A CUSTOMER IN THE UNITED STATES NOTIFIED BIOMÉRIEUX OF A DISCREPANT RESULT ASSOCIATED WITH THE VITEK® 2 AST-GP67 TEST KIT INVOLVING A PATIENT SPUTUM SAMPLE. AN INTERNAL BIOMÉRIEUX INVESTIGATION WAS PERFORMED. COMPARISON OF VITEK® 2 TO THE REFERENCE METHOD IS NEEDED IN ORDER TO CONFIRM A DISCREPANCY. WITHOUT THE ISOLATE, A DISCREPANCY CANNOT BE CONFIRMED. ON 11DEC2016 QC - VITEK ® AST-GP67 LOT 1320018403 MET FINAL QC RELEASE CRITERIA. THERE WERE NO ISSUES OBSERVED WITH VANCOMYCIN AND STAPH AUREUS ON INITIAL QC PERFORMANCE TESTING.

    Description of Event or Problem · 1

    A CUSTOMER IN THE UNITED STATES NOTIFIED BIOMÉRIEUX OF A DISCREPANT RESULT ASSOCIATED WITH THE VITEK® 2 AST-GP67 TEST KIT INVOLVING A PATIENT SPUTUM SAMPLE. THE CUSTOMER INDICATED THE VITEK® 2 AST-GP67 CARD PROVIDED A VANCOMYCIN RESISTANT STAPHYLOCOCCUS AUREUS (VRSA) RESULT. THE TECHNICIAN CHECKED THE PURITY PLATE AND IT APPEARED TO BE PURE SO TESTING WAS REPEATED USING THE VITEK® 2 AST-GP67 CARD, WHICH REVEALED THE SAME RESULT. THE VRSA RESULT WAS THEN REPORTED TO THE PHYSICIAN AND THE PATIENT WAS PLACED ON ISOLATION PRECAUTIONS. SUBSEQUENTLY, THE ISOLATE WAS SENT TO A REFERENCE LAB WHERE IT WAS REVEALED AS BEING VANCOMYCIN SUSCEPTIBLE. THE CUSTOMER PREPARED A FRESH ISOLATE AND PERFORMED TESTING A THIRD TIME WITH THE VITEK® 2 AST-GP67 CARD, WHICH REVEALED VANCOMYCIN SUSCEPTIBLE RESULT. THE CUSTOMER INDICATED OTHER THAN THE PATIENT BEING PUT ON ISOLATION PRECAUTIONS FOR SEVERAL DAYS, THERE WAS NO INJURY TO THE PATIENT. THE CUSTOMER REPORTED THE ISOLATE AS NO LONGER BEING AVAILABLE. AN INTERNAL BIOMÉRIEUX INVESTIGATION WILL BE INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    768103 VITEK® 2 AST-GP67 TEST KIT VITEK® 2 AST-GP67 TEST KIT LON BIOMERIEUX, INC. 1320018403

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention