BEUDAMED
    FDA Adverse Event Other Summary report: N

    ADVIA CENTAUR

    MDR report key: 656606 · Received December 23, 2005

    Report

    Report Number
    2432235-2005-00019
    Event Type
    Other
    Date Received
    December 23, 2005
    Date of Event
    October 20, 2005
    Report Date
    October 26, 2005
    Manufacturer
    BAYER DIAGNOSTICS MFG. LTD.
    Product Code
    LCI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    IN 2005, THE ER DOCTORS AT A HOSP QUESTIONED SEVERAL TROPONIN I RESULTS ON THE ADVIA CENTAUR ANALYZER. QC MATERIAL WAS RUN IN THE MORNING AND ALL LEVELS WERE IN. TIME: 07:18, LEVEL 1: 1.492, LEVEL 2: 1.827, LEVEL 3: 2.954. TIME: RANGES, LEVEL 1: 1.1-1.9, LEVEL 2: 1.4-2.6, LEVEL 3: 2.1-4.1. WHEN THE RESULTS WERE QUESTIONED LATER THAT DAY, QC'S WERE REPEATED ON THIS ANALYZER AND ALL LEVELS WERE OUT OF RANGE. AS A RESULT OF THE EARLIER TEST RESULTS, ONE PT UNDERWENT A CARDIAC CATHETERIZATION. INITIAL PT RESULT = 1.18 NG/ML. THE SAMPLES AND QC WERE RUN ON A SECOND CENTAUR ANALYZER AND THE QC WAS IN RANGE AND THE SAMPLES WERE NORMAL. REPEAT PT RESULT ON 2ND INSTRUMENT <0.15 NG/ML. THE OTHER FALSELY ELEVATED TROPONIN I VALUES DID NOT RESULT IN PT INTERVENTIONS.

    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 UNKNOWN Other