BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR XP CEA ASSAY

    MDR report key: 6138786 · Received December 1, 2016

    Report

    Report Number
    1219913-2016-00227
    Event Type
    Malfunction
    Date Received
    December 1, 2016
    Date of Event
    November 1, 2016
    Report Date
    January 5, 2017
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    DHX
    PMA / PMN Number
    K981478
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CAUSE FOR THE DISCORDANT ADVIA CENTAUR XP CEA RESULT IS UNKNOWN. THE QUALITY CONTROL AND CALIBRATION WERE ACCEPTABLE. THIS WAS THE ONLY PATIENT SAMPLE THAT WAS QUESTIONED. THEREFORE, AN INSTRUMENT ISSUE IS NOT SUSPECTED. SIEMENS HEALTHCARE DIAGNOSTICS HAS REQUESTED THE PATIENT SAMPLES FOR FURTHER TESTING AND INVESTIGATION. THE INSTRUCTION FOR USE (IFU) LIMITATION SECTION STATES: "NOTE: DO NOT INTERPRET LEVELS OF CEA AS ABSOLUTE EVIDENCE OF THE PRESENCE OR THE ABSENCE OF MALIGNANT DISEASE. MEASUREMENTS OF CEA SHOULD ALWAYS BE USED IN CONJUNCTION WITH OTHER DIAGNOSTIC PROCEDURES, INCLUDING INFORMATION FROM THE PATIENT'S CLINICAL EVALUATION. THE CONCENTRATION OF CEA IN A GIVEN SPECIMEN DETERMINED WITH ASSAYS FROM DIFFERENT MANUFACTURERS CAN VARY DUE TO DIFFERENCES IN ASSAY METHODS, CALIBRATION, AND REAGENT SPECIFICITY. CEA DETERMINED WITH DIFFERENT MANUFACTURERS' ASSAYS WILL VARY DEPENDING ON THE METHOD OF STANDARDIZATION AND ANTIBODY SPECIFICITY. WARNING: DO NOT USE THE ADVIA CENTAUR CEA IMMUNOASSAY AS A SCREENING TEST FOR DIAGNOSIS."

    Additional Manufacturer Narrative · 1

    SIEMENS FILED THE INITIAL MDR 1219913-2016-00227 ON DECEMBER 1, 2016. ON 2/21/2016 ADDITIONAL INFORMATION: THE CUSTOMER SENT FOUR TUBES (2 PRIMARY AND 2 POUR OFF TUBES) FOR FURTHER TESTING AND INVESTIGATION. THE POUR OFF TUBE FOR (B)(6) APPEARS TO BE HEMOLYZED. THE POUR OFF TUBE FOR (B)(6) DOES NOT HAVE ENOUGH VOLUME, SO IT WAS NOT TESTED. THEY WERE RECEIVED LIQUID AND NOT FROZEN. THE SAMPLES WERE TESTED WITH THREE LOTS OF ADVIA CENTAUR CEA REAGENT (040164, 040165, 040165) AND ALL THREE LOTS WERE CALIBRATED WITH TWO CALIBRATOR D LOTS (CD79 AND CD82). RESULTS: (B)(6). THE RESULTS OBTAINED BY SIEMENS ARE SIMILAR TO WHAT THE CUSTOMER OBSERVED. THERE IS NOT A LOT TO LOT ISSUE. BASED ON THE INFORMATION PROVIDED THERE IS AN UNIDENTIFIED ISSUE WITH SAMPLE (B)(6). THIS SAMPLE WAS RECEIVED BY SIEMENS HEMOLYZED. BASED ON THE INFORMATION PROVIDED, THERE WAS A POSSIBLE ISSUE WITH SAMPLE (B)(6). PRE-ANALYTIC VARIABLES CAN AFFECT THE QUALITY OF THE SAMPLE, AND DEVIATION FROM RECOMMENDED BEST PRACTICES CAN LEAD TO ERRONEOUS RESULTS. WHILE THERE IS INSUFFICIENT INFORMATION TO DETERMINE THE CAUSE OF THE DISCORDANT RESULT, SIEMENS CANNOT RULE OUT PRE-ANALYTICAL FACTORS OR SAMPLE ISSUE. THE CAUSE FOR THE DISCORDANT ADVIA CENTAUR XP CEA RESULT IS UNKNOWN. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED. THE ADVIA CENTAUR CEA IFU STATES IN THE INTERFERENCES SECTION FOR HEMOLYZED SPECIMENS: "SERUM SPECIMENS THAT ARE HEMOLYZED DEMONSTRATE A </= 5% CHANGE IN RESULTS UP TO 500 MG/DL OF HEMOGLOBIN."

    Description of Event or Problem · 1

    DISCORDANT ADVIA CENTAUR XP CEA RESULTS WERE OBTAINED ON TWO SAMPLES FROM THE SAME PATIENT WHEN TESTED WITH TWO DIFFERENT REAGENT LOT NUMBERS. THE PATIENT SAMPLE WAS TESTED WITH REAGENT LOT 164 AND THE RESULT WAS LOW. A SECOND PATIENT SAMPLE WAS TESTED ON REAGENT LOT 165 IN DUPLICATE AND THE RESULTS WERE HIGHER. THE RESULTS WERE REPORTED TO THE PHYSICIAN. THE PHYSICIAN WAS EXPECTING THE 2ND SAMPLE RESULTS TO BE AROUND 6 UG/L. BOTH PATIENT SAMPLES WERE REPEATED ON (B)(6) 2016 WITH REAGENT LOT 165. THE RESULTS WERE SIMILAR TO THE INITIAL RESULTS. PATIENT TREATMENT WAS NOT ALTERED OR PRESCRIBED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT ADVIA CENTAUR XP CEA RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    789508 ADVIA CENTAUR XP CEA ASSAY CEA IMMUNOASSAY DHX SIEMENS HEALTHCARE DIAGNOSTICS, INC. N/A 29490165

    Patients

    Seq Age Sex Outcome Treatment
    1