BEUDAMED
    FDA Adverse Event Summary report: N

    ADVIA CENTAUR CP TROPONIN ULTRA ASSAY

    MDR report key: 2012357 · Received March 9, 2011

    Report

    Report Number
    1219913-2011-00028
    Date Received
    March 9, 2011
    Date of Event
    February 18, 2011
    Report Date
    February 18, 2011
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    MMI
    PMA / PMN Number
    K053020
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS FIELD SERVICE ENGINEER (FSE) WAS SENT TO THE CUSTOMER SITE FOR SYSTEM INSPECTION. THE FSE FOUND BLEACH CONTAMINATION IN THE WASH 1 BOTTLE AND FLUSHED OUT THE WASH 1 BOTTLE, FLUID LINE AND PERFORMED AN AUTO SYSTEM PRIME ROUTINE. THE CUSTOMER INDICATED A NEW OPERATOR HAD CONTAMINATED WASH 1 BOTTLE WITH BLEACH. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    A FALSE POSITIVE ADVIA CENTAUR CP TROPONIN ULTRA RESULT WAS OBTAINED BY THE CUSTOMER ON A PATIENT SAMPLE. THE PATIENT SAMPLE WAS REPEATED ON AN ADVIA CENTAUR XP SYSTEM AND THE TROPONIN RESULT WAS NEGATIVE. A NEGATIVE TROPONIN TEST RESULT WAS REPORTED TO THE PHYSICIAN. PATIENT TREATMENT WAS NOT PRESCRIBED OR ALTERED. THERE WAS NO KNOWN REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT TROPONIN ULTRA RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADVIA CENTAUR CP TROPONIN ULTRA ASSAY TROPONIN IMMUNOASSAY MMI SIEMENS HEALTHCARE DIAGNOSTICS, INC. N/A 051

    Patients

    Seq Age Sex Outcome Treatment
    1