BEUDAMED
    FDA Adverse Event Other Summary report: N

    ADVIA CENTAUR

    MDR report key: 583256 · Received March 17, 2005

    Report

    Report Number
    2432235-2005-00005
    Event Type
    Other
    Date Received
    March 17, 2005
    Date of Event
    February 13, 2005
    Report Date
    February 18, 2005
    Manufacturer
    BAYER DIAGNOSTICS MFG. LTD.
    Product Code
    LCI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    IN 2005 A PT WAS ADMITTED TO THE HOSPITAL, ORIGINAL TESTING AT 03:52 AM RESULTED IN A TROPONIN VALVE OF 1.93 NG/ML AND A CKMB OF 4.5. CONTROLS RUN PRIOR TO THE ORIGINAL TEST WERE OUT OF RANGE. THE ORIGINAL RESULTS WERE REPORTED TO THE PHYSICIAN EVEN THOUGH THE CONTROLS WERE OUT OF RANGE. SUBSEQUENT TESTING AT 09:43 YIELDED RESULTS OF <0.10 NG/ML FOR TROPONIN I AND 0.7 NG/ML FOR CKMB. CUSTOMER RAN AN ASPIRATE 1 DISPENSE TEST AS INDICATED IN THE INSTRUCTIONS FOR USE TO TROUBLLESHOOT THE INSTRUMENT AND DISCOVERED THE ASPIRATE CUVETTE OVERFLOWING. UPON THIS DISCOVERY THE CUSTOMER CALLED BAYER AND A FIELD ENGINEER WAS DISPATCHED. THE FIELD ENGINEER INSPECTED THE INSTRUMENT, FLUSHED OUT THE ASPIRATE LINE AND DISCOVERED A SLIGHT CLOG IN THE LINE. AFTER TROUBLESHOOTING THE FIELD ENGINEER RAN CONTROLS AGAIN AND THEY WERE IN RANGE. ON THE 5TH DAY BAYER WAS NOTIFIED BY THE HOSPITAL LABORATORY THAT THE PHYSICIAN ACTED ON THE ORIGINAL RESULTS AND THE PT UNDERWENT A CARDIAC CATHETERIZATION DUE TO THE INITIAL ELEVATED TROPONIN RESULT ON THE ADVIA CENTAUR. BAYER INSTRUCTIONS FOR USE INDICATE THAT IF THE QUALITY CONTROL MATERIALS DO NOT FALL WITHIN THE EXPECTED VALUES OR WITHIN THE LABORATORY'S EXPECTED VALUES THE OPERATOR SHOULD REVIEW THE INSTRUCTIONS FOR USE TO ENSURE THE ASSAY WAS PERFORMED ACCORDING TO THE PROCEDURES RECOMMENDED BY BAYER; VERIFY THAT THE MATERIALS ARE NOT EXPIRED; VERIFY THAT REQUIRED MAINTENANCE WAS PERFORMED AND IF NECESSARY, RERUN THE QUALITY CONTROL SAMPLES OR CONTACT BAYER FOR MORE ASSISTANCE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other