BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATELLICA IM CARCINOEMRYOINIC (CEA)

    MDR report key: 11146363 · Received January 11, 2021

    Report

    Report Number
    1219913-2021-00051
    Event Type
    Malfunction
    Date Received
    January 11, 2021
    Date of Event
    December 17, 2020
    Report Date
    March 24, 2021
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    DHX
    UDI-DI
    00630414598505
    PMA / PMN Number
    K981478
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    SIEMENS HEALTHCARE DIAGNOSTICS FILED MDR 1219913-2021-00051 INITIAL REPORT ON (B)(6) 2021. ADDITIONAL INFORMATION - (B)(6) 2021: SIEMENS HAS COMPLETED THE INVESTIGATION FOR AN IMPRECISIE (DISCORDANT, ELEVATED) ATELLICA IM CARCINOEMRYOINIC (CEA) PATIENT RESULT. SIEMENS REVIEWED THE AVAILABLE INFORMATION TO DETERMINE PROBABLE ROOT CAUSE FOR THE IMPRECISION. INSTRUMENT SAMPLE AND REAGENT ASPIRATIONS WERE REVIEWED VIA INSTRUMENT LOG FILES. ASPIRATIONS SUCCESSFULLY COMPLETED AND DID NOT SHOW ANY ANOMALIES IN THE TRACES. NO ERRORS ARE SHOWN IN THE ICDEBUG LOG DURING PROCESSING OF THE SAMPLE. THE AVAILABLE DATA DOES NOT INDICATE A HARDWARE ISSUE HAS CAUSED THE DISCORDANT RESULTS. ACCORDING TO THE DETECTION CAPABILITY SECTION OF THE ATELLICA IM CEA INSTRUCTIONS FOR USE (IFU), "THE LOQ CORRESPONDS TO THE LOWEST AMOUNT OF CARCINOGENIC ANTIGEN IN A SAMPLE AT WHICH THE WITHIN LABORATORY CV IS </=20%. THE LOQ OF THE ATELLICA IM CEA ASSAY IS 1.25 NG/ML, AND WAS DETERMINED USING MUTIPLE PATIENT SAMPLES IN THE INTERVAL 0.84-9.16 NG/ML." THE % CV ON THE CUSTOMER PATIENT SAMPLE REPLICATES IS 19.8%, SO IS WITHIN THE EXPECTED RANGE FOR A SAMPLE AT THIS CONCENTRATION. PATIENT HISTORY AND SAMPLE PROCESSING INFORMATION WAS REQUESTED BY SIEMENS, BUT WAS NOT AVAILABLE. ATELLICA IM CEA READYPACKS REQUIRE VIGOROUS RESUSPENSION AS STATED IN THE PREPARING REAGENTS SECTION OF THE ATELLICA IM CEA IFU, "SHAKE VIGOROUSLY FOR 15 SECONDS, USING A BACK AND FORTH MOTION." SIEMENS CANNOT RULE OUT THAT REAGENT MIXING AND/OR PRE-ANALYTICAL SAMPLE HANDLING MAY HAVE CAUSED INCREASED PRECISION FOR THIS SAMPLE. BASED ON THE INVESTIGATION, A PRODUCT PROBLEM WAS NOT IDENTIFIED. IN SECTION H6, THE INVESTIGATION FINDING, AND INVESTIGATION CONCLUSION CODES WERE UPDATED BASED ON THE INVESTIGATION RESULTS.

    Additional Manufacturer Narrative · 0

    SIEMENS HEALTHCARE DIAGNOSTICS FILED MDR 1219913-2021-00051 INITIAL REPORT ON 2021-01-11 AND MDR 1219913-2021-00051 SUPPLEMENTAL 1 REPORT 2021-02-25. CORRECTION - 2021-03-17: SIEMENS' INVESTIGATION FOR THIS EVENT WAS PREVIOUSLY COMPLETED AS DOCUMENTED IN MDR 1219913-2021-00051 SUPPLEMENTAL 1 REPORT. HOWEVER, ON 2020-03-17 A CORRECTION TO THE SAMPLE ID WAS PROVIDED TO SIEMENS. THE SAMPLE ID INITIALLY REPORTED FOR THIS EVENT WAS SAMPLE ID "(B)(6)", BUT THE CORRECT SAMPLE ID FOR THIS EVENT IS "(B)(6)".

    Additional Manufacturer Narrative · 1

    SIEMENS HEALTHCARE DIAGNOSTICS IS INVESTIGATING THIS EVENT. THE LIMITATIONS SECTION OF THE INSTRUCTIONS FOR USE STATES THE FOLLOWING: "WARNING DO NOT USE THE ATELLICA IM CEA ASSAY 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."

    Description of Event or Problem · 1

    A CUSTOMER OBSERVED A DISCORDANT, ELEVATED ATELLICA IM CARCINOEMRYOINIC (CEA) RESULT. THE DISCORDANT RESULT WAS NOT REPORTED TO THE PHYSICIAN. THE SAMPLE WAS RETESTED TWICE AND RESULTS WERE LOWER. ONE OF THE RETEST RESULTS WAS REPORTED TO THE PHYSICIAN. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT CEA RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    44894 ATELLICA IM CARCINOEMRYOINIC (CEA) CEA IMMMUNOASSAY DHX SIEMENS HEALTHCARE DIAGNOSTICS, INC. N/A 198 00630414598505

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR