BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR CA 19-9 ASSAY

    MDR report key: 3426057 · Received October 23, 2013

    Report

    Report Number
    1219913-2013-00257
    Event Type
    Malfunction
    Date Received
    October 23, 2013
    Date of Event
    October 3, 2013
    Report Date
    October 3, 2013
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    NIG
    PMA / PMN Number
    K031393
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SIEMENS FILED THE INITIAL MDR 1219913-2013-00257 ON OCTOBER 23, 2013. 02/26/2014 ADDITIONAL INFORMATION: THE CUSTOMER OBSERVED DISCORDANT RESULTS DURING A CORRELATION STUDY BETWEEN LOT # 052340 AND LOT # 052342. SIEMENS HEALTHCARE DIAGNOSTICS HAS PERFORMED AN INTERNAL INVESTIGATION. THE INTERNAL INVESTIGATION INDICATED THAT REAGENT LOT 052340 YIELDED LOWER PATIENT RESULTS THAN THE CURRENT REAGENT LOTS IN USE. A REVIEW OF THE QUALITY CONTROL RELEASE DATA SHOWED A SIMILAR DROP IN VALUE FOR LOT# 052340 WHEN COMPARED TO LOT# 052338. THE TOTAL ALLOWABLE ERROR FOR THIS ASSAY IS 39%. THE BIAS OBSERVED WITH LOT 052340 IS WITHIN THE TOTAL ALLOWABLE ERROR. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED. THE IFU STATES IN THE LIMITATIONS SECTION: "NOTE: DO NOT INTERPRET SERUM LEVELS OF CA 19-9 AS ABSOLUTE EVIDENCE OF THE PRESENCE OR THE ABSENCE OF MALIGNANT DISEASE. BEFORE TREATMENT, PATIENTS WITH CONFIRMED GI CARCINOMA FREQUENTLY HAVE LEVELS OF CA 19-9 WITHIN THE RANGE OBSERVED IN HEALTHY INDIVIDUALS. ADDITIONALLY, ELEVATED LEVELS OF CA 19-9 CAN BE OBSERVED IN PATIENTS WITH NONMALIGNANT DISEASES. MEASUREMENTS OF CA 19-9 SHOULD ALWAYS BE USED IN CONJUNCTION WITH OTHER DIAGNOSTIC PROCEDURES, INCLUDING INFORMATION FROM THE PATIENT'S CLINICAL EVALUATION. WARNING: DO NOT USE THE ADVIA CENTAUR CA 19-9 ASSAY AS A SCREENING TEST OR FOR DIAGNOSIS. DO NOT PREDICT DISEASE RECURRENCE SOLELY ON LEVELS OF ADVIA CENTAUR CA 19-9. NORMAL LEVELS OF ADVIA CENTAUR CA 19-9 DO NOT ALWAY S PRECLUDE THE PRESENCE OF DISEASE."

    Additional Manufacturer Narrative · 1

    THE CAUSE FOR THE DISCORDANT ADVIA CENTAUR CA19-9 RESULTS IS UNKNOWN. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED. THE IFU STATES IN THE LIMITATIONS SECTION: "NOTE: DO NOT INTERPRET SERUM LEVELS OF CA 19-9 AS ABSOLUTE EVIDENCE OF THE PRESENCE OR THE ABSENCE OF MALIGNANT DISEASE. BEFORE TREATMENT, PATIENTS WITH CONFIRMED GI CARCINOMA FREQUENTLY HAVE LEVELS OF CA 19-9 WITHIN THE RANGE OBSERVED IN HEALTHY INDIVIDUALS. ADDITIONALLY, ELEVATED LEVELS OF CA 19-9 CAN BE OBSERVED IN PATIENTS WITH NONMALIGNANT DISEASES. MEASUREMENTS OF CA 19-9 SHOULD ALWAYS BE USED IN CONJUNCTION WITH OTHER DIAGNOSTIC PROCEDURES, INCLUDING INFORMATION FROM THE PATIENT'S CLINICAL EVALUATION. WARNING: DO NOT USE THE ADVIA CENTAUR CA 19-9 ASSAY AS A SCREENING TEST OR FOR DIAGNOSIS. DO NOT PREDICT DISEASE RECURRENCE SOLELY ON LEVELS OF ADVIA CENTAUR CA 19-9. NORMAL LEVELS OF ADVIA CENTAUR CA 19-9 DO NOT ALWAYS PRECLUDE THE PRESENCE OF DISEASE."

    Description of Event or Problem · 1

    DISCORDANT ADVIA CENTAUR CA 19-9 RESULTS WERE OBTAINED FOR PATIENT SAMPLES DURING A CORRELATION STUDY. SOME OF THE SAMPLES DISPLAYED HIGHER RESULTS WITH THE NEW REAGENT LOT. PATIENT TREATMENT WAS NOT PRESCRIBED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT CA 19-9 RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    545429 ADVIA CENTAUR CA 19-9 ASSAY IMMUNOLOGICAL TEST FOR CA 19-9 ANTIGEN NIG SIEMENS HEALTHCARE DIAGNOSTICS, INC. N/A 052342

    Patients

    Seq Age Sex Outcome Treatment
    1