BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR XPT CEA

    MDR report key: 8654231 · Received May 30, 2019

    Report

    Report Number
    1219913-2019-00099
    Event Type
    Malfunction
    Date Received
    May 30, 2019
    Date of Event
    May 8, 2019
    Report Date
    July 30, 2019
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    DHX
    UDI-DI
    00630414177304
    PMA / PMN Number
    K981478
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    SIEMENS FILED THE INITIAL MDR 1219913-2019-00099 ON MAY 30, 2019. SIEMENS FILED THE MDR 1219913-2019-00099 SUPPLEMENTAL REPORT 1 ON JUNE 25, 2019. ON 07/17/2019 ADDITIONAL INFORMATION: THE CUSTOMER HAS TRANSITIONED TO THE NEW ANTIBODY POOL. IT WAS A SMALL PROPORTION OF PATIENTS IN WHOM RE-BASELINING WAS CONDUCTED, WHO WERE UNDERGOING CHEMOTHERAPY AND FREQUENT (WEEKLY) CEA MONITORING. ON 07/24/2019: ADVIA CENTAUR XPT CEA LOT 040185 PATIENT SHIFT OBSERVED WHEN RE-BASELINING SAMPLES FROM PATIENTS UNDERGOING CHEMOTHERAPY AND WEEKLY CEA MONITORING. SIEMENS TECHNICAL OPERATIONS PERFORMED TWO ADDITIONAL STUDIES, A METHOD COMPARISON AND REFERENCE INTERVAL STUDY. THE METHOD COMPARISON CONSISTED OF 99 SAMPLES THROUGHOUT THE ASSAY MEASURING RANGE (0.5-100 NG/ML) TESTED WITH CEA REAGENT LOT 040178 CALIBRATED WITH CD95 AND CEA REAGENT LOT 040185 CALIBRATED WITH CD05. A BIAS OF 6% WAS OBSERVED BETWEEN THE TWO REAGENT LOT, CALIBRATOR LOT COMBINATIONS. THE REFERENCE INTERVAL STUDY WAS PERFORMED USING 30 NORMAL, NON-SMOKER SERUM SAMPLES TESTED WITH CEA REAGENT LOT 040178 CALIBRATED WITH CD95 AND CEA REAGENT LOT 040185 CALIBRATED WITH CD05. NO CHANGE IN THE REFERENCE INTERVAL WAS OBSERVED BETWEEN THE TWO REAGENT LOT, CALIBRATOR LOT COMBINATIONS. THE SAMPLES USED BY THE ACCOUNT IN THE METHOD COMPARISON WERE OFF CURVE SAMPLES AND WERE DILUTED. THE CUSTOMER BULLETIN NEW LOT OF LITE REAGENT ANTIBODY FOR THE CARCINOEMBRYONIC ANTIGEN (CEA) ASSAY (11419805, REV. A) RELEASED IN FEBRUARY 2019, STATES THE DILUTION RECOVERY PERFORMANCE CHARACTERISTIC HAS CHANGED AS A RESULT OF THE NEW LOT OF LITE REAGENT ANTIBODY. PREVIOUS DILUTION RECOVERY: SIX SERUM SAMPLES IN THE RANGE OF 55.85 TO 77.02 NG/ML (UG/L) OF CEA WERE DILUTED 1:2, 1:4, 1:8, AND 1:16 WITH CEA DILUENT AND ASSAYED FOR RECOVERY AND PARALLELISM. THE RECOVERIES RANGED FROM 79.2% TO 110.9% WITH A MEAN OF 96.8%. UPDATED DILUTION RECOVERY: FIVE SERUM SAMPLES IN THE RANGE OF 80.00 TO 93.69 NG/ML (UG/L) OF CEA WERE DILUTED 1:2, 1:4, 1:8, AND 1:16 WITH CEA DILUENT AND ASSAYED FOR RECOVERY AND PARALLELISM. THE RECOVERIES RANGED FROM 107.6 TO 138.3% WITH A MEAN OF 118.0%. BASED ON THE INFORMATION PROVIDED, NO PRODUCT PROBLEM HAS BEEN IDENTIFIED. THE CUSTOMER HAS TRANSITIONED TO THE REAGENT LOT CONTAINING NEW ANTIBODY POOL. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Additional Manufacturer Narrative · 0

    SIEMENS FILED THE INITIAL MDR (B)(4) ON (B)(6) 2019. (B)(6) 2019 ADDITIONAL INFORMATION: THE CUSTOMER HAS SWITCHED TO CEA LOT 040185 WITH THE NEW ANTIBODY POOL FOR PATIENT TESTING. THE COMPARISON RESULTS WERE REPORTED WITH THE PREVIOUS LOT. SINCE MOVING TO THE NEW CEA LOT 040185, TEN PATIENT SAMPLES WITH RESULTS ABOVE THE MEASURING RANGE WERE SELECTED TO BE RE-ANALYSED USING THE PREVIOUS LOT. FOR 2 OUT OF 10 PATIENT SAMPLES, RESULTS WERE REPORTED WITH BOTH THE NEW CEA LOT AND THE PREVIOUS CEA LOT. FOR 8 OUT OF 10 PATIENT SAMPLES, RESULTS WERE REPORTED WITH THE NEW CEA LOT ONLY. THE ACTUAL RESULTS WERE NOT PROVIDED. SIEMENS HEALTHCARE DIAGNOSTICS CONTINUES TO INVESTIGATE.

    Additional Manufacturer Narrative · 1

    THE CAUSE FOR THE DISCORDANT ADVIA CENTAUR XPT CEA RESULT IS UNKNOWN. SIEMENS HEALTHCARE DIAGNOSTICS IS INVESTIGATING. THE INSTRUCTION FOR USE (IFU) IN THE INTERPRETATION OF RESULTS SECTION STATES: "RESULTS OF THIS ASSAY SHOULD ALWAYS BE INTERPRETED IN CONJUNCTION WITH PATIENT'S MEDICAL HISTORY, CLINICAL PRESENTATION AND OTHER FINDINGS." THE INSTRUCTION FOR USE (IFU) IN THE LIMITATIONS SECTION STATES: "WARNING DO NOT USE THE ADVIA CENTAUR CEA IMMUNOASSAY AS A SCREENING TEST FOR DIAGNOSIS. 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."

    Description of Event or Problem · 1

    DISCORDANT ADVIA CENTAUR XPT CEA RESULTS WERE OBTAINED ON SAMPLES FROM FOUR PATIENTS DURING A COMPARISON STUDY. THE COMPARISON STUDY WAS COMPARING THE PREVIOUS LOT WITH THE NEW LOT THAT CONTAINED A NEW ANTIBODY POOL. THE RESULTS WITH THE NEW LOT WERE HIGHER. PATIENT TREATMENT WAS NOT ALTERED OR PRESCRIBED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT ADVIA CENTAUR XPT CEA RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    449467 ADVIA CENTAUR XPT CEA CEA IMMUNOASSAY DHX SIEMENS HEALTHCARE DIAGNOSTICS, INC. N/A 41279185 00630414177304

    Patients

    Seq Age Sex Outcome Treatment
    1