BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR XP CEA ASSAY

    MDR report key: 6228761 · Received January 6, 2017

    Report

    Report Number
    1219913-2016-00274
    Event Type
    Malfunction
    Date Received
    January 6, 2017
    Date of Event
    December 15, 2016
    Report Date
    March 1, 2017
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    DHX
    PMA / PMN Number
    K981478
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE CAUSE FOR THE DISCORDANT ADVIA CENTAUR XP CEA RESULT WITH LOT 166 IS UNKNOWN. THE CUSTOMER IS CURRENTLY USING CEA LOT 167 AND HAS MODIFIED THE QUALITY CONTROL RANGES. SIEMENS HEALTHCARE DIAGNOSTICS IS INVESTIGATING. 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 1219913-2016-00274 ON JANUARY 6, 2017. ON 02/22/2017 ADDITIONAL INFORMATION: THE INVESTIGATION WAS COMPRISED OF TESTING ADVIA CENTAUR CEA REAGENT (LOTS 040166 AND 040167), CALIBRATOR D (LOTS 79 AND 82), MULTIPLE BIORAD QC (QUALITY CONTROL) LOTS (23910, 23921, 40310, 40320, 40880, 40890, 40900, 54600 AND 77160), AND 10 PATIENT SAMPLES. ALL OF THE BIORAD QC TESTED WERE WITHIN PACKAGE INSERT RANGES. THE LARGEST OBSERVED PERCENT BIAS WITH CEA LOT 040166 VERSUS CEA LOT 040167 WITH CD79 WAS 15% (BIORAD CONTROL LOT 23922). THE LARGEST OBSERVED PERCENT BIAS WITH CEA LOT 040166 VERSUS CEA LOT 040167 WITH CD82 WAS 16% (BIORAD CONTROL LOT 56402). THE LARGEST PERCENT BIAS TO THE BIORAD QC TARGET OBSERVED OVERALL WAS WITH THE BIORAD QC LOT 54602 WITH CEA LOT 040166 WITH CD82 AT 20%. SIEMENS REVIEWED THE JANUARY 2017 PEER DATA FOR THESE TWO CONTROLS AND THE RESULTS OBTAINED WERE WITHIN THE 2SD PEER RANGE. THE AVERAGE PERCENT BIAS BETWEEN CEA LOT 040166 AND LOT 040167 IS 4%. THE AVERAGE PERCENT BIAS BETWEEN CEA LOTS 040166 AND 040167 IS 1% FOR THE 10 PATIENT SAMPLES TESTED. THE DOSES OF THE 10 SAMPLES RANGED FROM 0.67 NG/ML TO 10.6 NG/ML. THE HIGHEST PATIENT BIAS OBSERVED WAS 11%. THE INVESTIGATION PERFORMED SHOWED THAT THERE IS AN OVERALL PERCENT BIAS OF 4% BETWEEN BOTH LOTS FOR THE BIORAD CONTROLS. THERE IS AN OVERALL PERCENT BIAS BETWEEN BOTH LOTS OF 1% WITH THE 10 PATIENT SAMPLES. ALL LOTS AND LEVELS OF THE BIORAD QC TESTED WERE WITHIN PACKAGE INSERT RANGES. THOSE QC LEVELS WITH HIGHEST OBSERVED BIAS (23922 AND 56402) WERE WELL WITHIN THE JANUARY 2017 2SD PEER RANGES. SIEMENS DOES NOT CONFIRM A PRODUCT ISSUE WITH CEA LOT 040166 AT THIS TIME. 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.

    Description of Event or Problem · 1

    DISCORDANT ADVIA CENTAUR XP CEA RESULTS WERE OBTAINED ON A PATIENT SAMPLE WHEN TESTED WITH TWO DIFFERENT REAGENT LOT NUMBERS. THE PATIENT SAMPLE WAS TESTED WITH REAGENT LOT 165 AND REAGENT LOT 166. THE RESULT FOR THE SAMPLE WAS HIGHER WITH REAGENT LOT 166. THE CUSTOMER ALSO OBSERVED A HIGH BIAS ON THE QUALITY CONTROL WITH LOT 166. THE PATIENT RESULTS WERE NOT REPORTED TO THE PHYSICIAN. 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
    13546 ADVIA CENTAUR XP CEA ASSAY CEA IMMUNOASSAY DHX SIEMENS HEALTHCARE DIAGNOSTICS, INC. N/A 52355166

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR