BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR TROPONIN ULTRA ASSAY

    MDR report key: 2786330 · Received October 12, 2012

    Report

    Report Number
    1219913-2012-00364
    Event Type
    Malfunction
    Date Received
    October 12, 2012
    Date of Event
    September 18, 2012
    Report Date
    September 18, 2012
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    MMI
    PMA / PMN Number
    K053020
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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 AND THE CAUSE FOR THE DISCORDANT TROPONIN RESULTS IS UNKNOWN AND BEING INVESTIGATED. ON FOLLOW UP SERVICE VISIT, THE FSE REPLACED THE FOLLOWING PRINTED CIRCUIT BOARDS, SEQUENCER CONTROLLER , PMT COUNTER, AND LLC STEPPER ON (B)(4) 2012. THE CUSTOMER WILL REPEAT ELEVATED TROPONIN RESULTS ON THEIR ALTERNATE ADVIA CENTAUR SYSTEM (IRL (B)(4)). IT WAS ALSO NOTED THAT THE CUSTOMER OBSERVED AN ELEVATED TROPONIN RESULT OF (0.111 NG/ML) ON A PATIENT SAMPLE JUST PRIOR TO THE FSE VISIT AND THE REPEAT RESULTS (0.0.52, 0.052 NG/ML) WAS LOWER WHEN RUN ON THEIR ALTERNATE ADVIA CENTAUR SYSTEM (IRL (B)(4)). NO CONCLUSION CAN BE DRAWN.

    Description of Event or Problem · 1

    FALSE POSITIVE ADVIA CENTAUR TROPONIN ULTRA RESULTS WERE OBTAINED BY THE CUSTOMER ON TWO PATIENT SAMPLES AND THE RESULTS WERE CONSIDERED DISCORDANT WHEN COMPARED TO NEGATIVE REPEAT TEST RESULTS RUN ON AN ALTERNATE ADVIA CENTAUR SYSTEM. THE CUSTOMER'S PROTOCOL IS TO REPEAT ELEVATED TROPONIN RESULTS ON THEIR ALTERNATE ADVIA CENTAUR SYSTEM. THERE WAS NO KNOWN REPORT OF PATIENT TREATMENT BEING ALTERED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT TROPONIN ULTRA RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADVIA CENTAUR TROPONIN ULTRA ASSAY TROPONIN IMMUNOASSAY MMI SIEMENS HEALTHCARE DIAGNOSTICS, INC. N/A 066

    Patients

    Seq Age Sex Outcome Treatment
    1