BEUDAMED
    FDA Adverse Event Other Summary report: N

    ADVIA CENTAUR

    MDR report key: 564623 · Received January 7, 2005

    Report

    Report Number
    2432235-2005-00001
    Event Type
    Other
    Date Received
    January 7, 2005
    Date of Event
    December 7, 2004
    Report Date
    December 9, 2004
    Manufacturer
    BAYER DIAGNOSTIC MFG. LTD.
    Product Code
    JJE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    IN 2004 A PT WAS ADMITTED TO THE HOSPITAL WITH CHEST PAINS, UPON TESTING AN INITIAL TROPONIN VALUE OF 12 NG/ML WAS REPORTED ON THE ADVIA CENTAUR. SUBSEQUENT TESTING IN THE FOLLOWING DAY YIELDED RESULTS OF 6.7 NG/ML AND 8.4 NG./ML, IN ADDITION A 1:2 DILUTION OF THE INITIAL SAMPLE YIELDED A RESULT OF 0 NG/ML. ALL LEVELS OF QUALITY CONTROL MATERIALS WERE WITHIN RANGE. OTHER RELEVANT TEST RESULTS WERE BNP = 282 PG/ML. ON THE 2ND DAY, BAYER WAS NOTIFIED BY THE HOSPITAL LABORATORY THAT THE PT UNDERWENT AN ELECTROCARDIOGRAM AND A CARDIAC CATHETERIZATION DUE TO THE INITIAL ELEVATED TROPONIN RESULT ON THE ADVIA CENTAUR. THERE WAS NO SIGNS OF MYOCARDIAL INFARCTION. THE INITIAL SAMPLE WAS SENT FOR RE-TEST TO A BAYER LABORATORY BECAUSE THE LABORATORY PATHOLOGIST SUSPECTED HETEROPHILIC ANTIBODY INTERFERENCE. FURTHER TESTING CONFIRMED THE OBSERVATIONS AT THE HOSPITAL LABORATORY AND A POSSIBLE PRESENCE OF A HETEROPHILIC ANTIBODY INTERFERENT. THE INSTRUCTIONS FOR USE FOR THE TROPONIN ASSAY ON THE ADVIA CENTAUR INDICATE HETEROPHILIC ANTIBODY INTERFERENCE AS A LIMITATION OF THE ASSAY. FOR MEDICAL DEVICE REPORTING PURPOSES THIS EVENT IS CONSIDERED CLOSED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other