BEUDAMED
    FDA Adverse Event Other Summary report: N

    ADVIA CENTAUR

    MDR report key: 508946 · Received January 8, 2004

    Report

    Report Number
    2432235-2003-00013
    Event Type
    Other
    Date Received
    January 8, 2004
    Date of Event
    December 3, 2003
    Report Date
    December 4, 2003
    Manufacturer
    BAYER DIAGNOSTICS MFG. LTD.
    Product Code
    GKL
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    A REFERENCE LABORATORY REPORTED THAT THE ADVIA CENTAUR HAD BEEN INVOLVED IN MISREPORTING RESULTS FROM NUMEROUS SAMPLES THAT WERE RUN FOR A VARIETY OF ASSAYS. THE LAB WAS NOTIFIED BY A PHYSICIAN THAT A REPORTED RESULT RUN IN 11/2003 WAS SUSPECT. THE LAB RETESTED THE SAMPLE AND CONFIRMED A PROBLEM, THEN SUBSEQUENTLY TESTED 20 SAMPLES ON EITHER SIDE OF THE MISREPORTED SAMPLE AND IDENTIFIED A ONE-SAMPLE-SHIFT. THE LAB REPORTED THAT UP TO 1,700 SAMPLES COULD HAVE BEEN INACCURATELY REPORTED TO PHYSICIANS. THIS REFERENCE LABORATORY HAS HAD THIS ADVIA CENTAUR INSTALLED SINCE 6/2001. IN 3/2003 IT WAS INTEGRATED INTO A LABORATORY AUTOMATION SYSTEM (LAS), NOT MANUFACTURED BY BAYER. IT IS AS PART OF THIS INTEGRATION THAT THE MISREPORTED EVENTS OCCURRED. PRIOR TO THE INTEGRATION WITH THE LAS THIS REFERENCE LABORATORY HAD NOT HAD ANY SIMILAR COMPLAINTS RELATED TO THE ADVIA CENTAUR. IN ADDITION, AFTER THESE EVENTS, THE LABORATORY HAS OPERATED THE ADVIA CENTAUR OUTSIDE OF THE LABORATORY AUTOMATION ENVIRONMENT AND IT HAS PERFORMED ACCORDING TO CUSTOMER EXPECTATION AND IN AGREEMENT WITH PRODUCT CLAIMS. AT THIS TIME BAYER BELIEVES THAT THE MISREPORTED RESULTS WERE CAUSED BY A ONE-SAMPLE-SHIFT OF SAMPLE IDENTIFICATION NUMBERS BETWEEN THE ADVIA CENTAUR AND THE SOFTWARE INTERFACE OF THE LAS. CENTAUR SPECIFICATIONS RECOMMENDED THAT WHEN THE INSTRUMENTS IS INCORPORATED INTO AN LAS SETTING, IT BE EQUIPPED WITH A BARCODE READER AT THE POINT OF SAMPLE ASPIRATION. THIS IS CURRENTLY NOT THE CASE AT THIS PARTICULAR LOCATION. AT THIS REFERENCE LABORATORY THE LAS SOFTWARE CONTROLS THE ISSUING OF SAMPLE IDENTIFICATIONS AND THE ROUTING OF THE SAMPLE, THERE IS SECONDARY VERIFICATION OF THE SAMPLE ID BUT IT IS NOT THE SAMPLE ASPIRATION POINT OF THE ADVIA CENTAUR. THE SECONDARY SAMPLE ID READER IS POSITIONED AT A POINT ON THE ROUTING TRACK BEFORE THE ADVIA CENTAUR SAMPLE ASPIRATION POINT, BUT AT A GUARDED POSITION WHERE THE TRACK IS NO LONGER ACCESSIBLE BY LABORATORY PERSONNEL. AT PRESENT TIME IT IS KNOWN THAT THIS SHIFT IN SAMPLE IDENTIFICATIONS HAS CONTRIBUTED TO PHYSICIANS ORDERING AT LEAST ONE BIOPSY AND IMMUNIZING ONE PT FOR RUBELLA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADVIA CENTAUR IMMUNOASSAY SYSTEM GKL BAYER DIAGNOSTICS MFG. LTD. ADVIA CENTAUR *

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other