BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR XP BR (ASSAY FOR CA 27.29)

    MDR report key: 2873689 · Received December 14, 2012

    Report

    Report Number
    1219913-2012-00410
    Event Type
    Malfunction
    Date Received
    December 14, 2012
    Date of Event
    November 16, 2012
    Report Date
    November 16, 2012
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    MOI
    PMA / PMN Number
    K982680
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CAUSE FOR THE LOWER ADVIA CENTAUR XP BR RESULT WHEN COMPARED TO AN ALTERNATE BR TEST METHOD IS UNKNOWN. THE CUSTOMER HAS OBSERVED QUALITY CONTROL RESULTS WITHIN RANGE LIMITS. THERE IS NO DISCORDANT SAMPLES AVAILABLE FOR FURTHER INVESTIGATION. NO CONCLUSION CAN BE DRAWN. THE IFU STATES IN THE LIMITATIONS SECTION STATES THE FOLLOWING: "WARNING DO NOT USE THE ADVIA CENTAUR BR ASSAY AS A SCREENING TEST OR FOR DIAGNOSIS. NORMAL LEVELS OF CA 27.29 DO NOT ALWAYS PRECLUDE THE PRESENCE OF DISEASE. HETEROPHILIC ANTIBODIES IN HUMAN SERUM CAN REACT WITH REAGENT IMMUNOGLOBULINS, INTERFERING WITH IN VITRO IMMUNOASSAYS. PATIENTS ROUTINELY EXPOSED TO ANIMALS OR TO ANIMAL SERUM PRODUCTS CAN BE PRONE TO THIS INTERFERENCE AND ANOMALOUS VALUES MAY BE OBSERVED. ADDITIONAL INFORMATION MAY BE REQUIRED." "NOTE DO NOT INTERPRET LEVELS OF CA 27.29 AS ABSOLUTE EVIDENCE OF THE PRESENCE OR THE ABSENCE OF MALIGNANT DISEASE. BEFORE TREATMENT, PATIENTS WITH CONFIRMED BREAST CARCINOMA FREQUENTLY HAVE LEVELS OF CA 27.29 WITHIN THE RANGE OBSERVED IN HEALTHY INDIVIDUALS. ADDITIONALLY, ELEVATED LEVELS OF CA 27.29 CAN BE OBSERVED IN PATIENTS WITH NONMALIGNANT DISEASES. MEASUREMENTS OF CA 27.29 SHOULD ALWAYS BE USED IN CONJUNCTION WITH OTHER DIAGNOSTIC PROCEDURES, INCLUDING INFORMATION FROM THE PATIENT'S CLINICAL EVALUATION." "EXERCISE CAUTION WHEN INTERPRETING ADVIA CENTAUR BR LEVELS DURING PREGNANCY. THE CONCENTRATION OF CA 27.29 IN A GIVEN SPECIMEN DETERMINED WITH ASSAYS FROM DIFFERENT MANUFACTURERS CAN VARY BECAUSE OF DIFFERENCES IN ASSAY METHODS, CALIBRATION, AND REAGENT SPECIFICITY. CA 27.29 DETERMINED WITH DIFFERENT MANUFACTURERS' ASSAYS WILL VARY DEPENDING ON THE METHOD OF STANDARDIZATION AND ANTIBODY SPECIFICITY. THEREFORE, IT IS IMPORTANT TO USE ASSAY-SPECIFIC VALUES TO EVALUATE QUALITY CONTROL RESULTS." THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    A FALSE LOW ADVIA CENTAUR BR (CA 27.29) RESULT WAS OBTAINED ON A PATIENT SAMPLE AND CONSIDERED DISCORDANT WHEN COMPARED TO AN ALTERNATE BR TEST METHOD. THE CUSTOMER WAS PERFORMING A COMPARISION STUDY WITH AN ALTERNATE TEST METHOD AND THE DIFFERENCE IN RESULT WAS GREATER THAN WHAT HAS BEEN OBSERVED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT LOW BR ASSAY RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADVIA CENTAUR XP BR (ASSAY FOR CA 27.29) CA 27.29 ANTIGEN IMMUNOASSAY MOI SIEMENS HEALTHCARE DIAGNOSTICS, INC. N/A 203

    Patients

    Seq Age Sex Outcome Treatment
    1