BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR XP CA 125 II ASSAY

    MDR report key: 1944722 · Received December 10, 2010

    Report

    Report Number
    1219913-2010-00144
    Event Type
    Malfunction
    Date Received
    December 10, 2010
    Date of Event
    November 29, 2010
    Report Date
    November 10, 2010
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    LTK
    PMA / PMN Number
    K020828
    Removal / Correction Number
    078DOTBD-01
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CAUSE FOR THE DISCORDANT CA 125 II RESULTS IS UNDER INVESTIGATION. URGENT DEVICE RECALL 078DOTBD-01 WILL BE ISSUED ON DECEMBER 2010.

    Additional Manufacturer Narrative · 1

    SIEMENS FILED THE INITIAL MDR ON (B)(4), 2010.(B)(4) 2012: ADDITIONAL INFORMATION:THE INVESTIGATION HAS SHOWN THE WETCAKE FOR (B)(4) LOT 144 WAS UNSTABLE AND DEMONSTRATED THE HIGH BIAS. (B)(4): 1219913-12-14-2010-001-R.

    Description of Event or Problem · 1

    DISCORDANT ADVIA CENTAUR XP CA 125 II RESULTS WERE OBTAINED FOR PT SAMPLES. THE CUSTOMER OBSERVED THAT THE PT RESULTS WERE HIGHER WHEN USING LOT 144 IN COMPARISON TO LOT 141. THE HIGH BIAS IN PT VALUES OBTAINED WERE NOT REFLECTED IN THE QC VALUES. PT TREATMENT WAS NOT PRESCRIBED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT CA 125 II RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADVIA CENTAUR XP CA 125 II ASSAY CA 125 II IMMUNOASSAY LTK SIEMENS HEALTHCARE DIAGNOSTICS INC. NA 144

    Patients

    Seq Age Sex Outcome Treatment
    1