BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATELLICA IM CA 19-9 (CA19-9)

    MDR report key: 15348233 · Received September 2, 2022

    Report

    Report Number
    1219913-2022-00271
    Event Type
    Malfunction
    Date Received
    September 2, 2022
    Date of Event
    August 16, 2022
    Report Date
    October 7, 2022
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    NIG
    UDI-DI
    00630414598161
    PMA / PMN Number
    K031393
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN OUTSIDE OF THE UNITED STATES (OUS) CUSTOMER CONTACTED THE SIEMENS CUSTOMER CARE CENTER TO REPORT AN OBSERVATION OF FALSELY ELEVATED RESULTS WITH THE ATELLICA IM CA 19-9 ASSAY. QUALITY CONTROL (QC) WAS WITHIN ACCEPTABLE RANGES. THE CUSTOMER PERFORMED MANUAL DILUTIONS ON THE 2 AFFECTED SAMPLES AND RESULTS WERE ALSO ELEVATED. THE SAMPLES WERE ALSO TESTED AFTER PEG6000 TREATMENT AND RESULTS WERE ALSO ELEVATED. THE INSTRUCTIONS FOR USE (IFU) STATES: "WARNING THE CONCENTRATION OF CA 19-9 IN A GIVEN SPECIMEN, AS DETERMINED BY ASSAYS FROM DIFFERENT MANUFACTURERS, CAN VARY DUE TO DIFFERENCES IN ASSAY METHODS AND REAGENT SPECIFICITY. THE RESULTS REPORTED BY THE LABORATORY TO THE PHYSICIAN MUST INCLUDE THE IDENTITY OF THE ASSAY FOR CA 19-9 USED. VALUES OBTAINED WITH DIFFERENT ASSAY METHODS CANNOT BE USED INTERCHANGEABLY. IF, IN THE COURSE OF MONITORING A PATIENT, THE ASSAY METHOD USED FOR DETERMINING SERIAL LEVELS OF CA 19-9 IS CHANGED, THE LABORATORY MUST PERFORM ADDITIONAL SERIAL TESTING TO CONFIRM BASELINE VALUES. THE ATELLICA IM CA 19-9 ASSAY IS BASED ON THE 1116-NS-19-9 ANTIBODY AVAILABLE THROUGH AGREEMENT WITH FUJIREBIO DIAGNOSTICS, INC. ASSAYS USING ANTIBODIES OTHER THAN 1116-NS-19-9 MAY GIVE DIFFERENT RESULTS." "WARNING DO NOT USE THE ATELLICA IM CA 19-9 ASSAY AS A SCREENING TEST OR FOR DIAGNOSIS. DO NOT PREDICT DISEASE RECURRENCE SOLELY ON LEVELS OF ATELLICA IM CA 19-9. NORMAL LEVELS OF ATELLICA IM CA 19-9 DO NOT ALWAYS PRECLUDE THE PRESENCE OF DISEASE." "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." SIEMENS IS INVESTIGATING.

    Additional Manufacturer Narrative · 0

    SIEMENS HEALTHCARE DIAGNOSTICS FILED MDR INITIAL REPORT ON 2022-09-02. CORRECTION - 2022-10-07. THIS REPORT CONTAINS CORRECTED INFORMATION IN SECTION D4 FOR THE PRODUCT LOT NUMBER AND EXPIRATION DATE AND IN SECTION H4 FOR THE PRODUCT MANUFACTURE DATE. THIS CORRECTION IS REQUIRED BECAUSE AT THE TIME MDR INITIAL REPORT WAS FILED (2022-09-02), THE COMPLAINT INFORMATION WAS UNCLEAR. AFTER INVESTIGATION, IT WAS CONFIRMED THAT THE INITIAL RESULTS WERE GENERATED WITH LOT 506 AND NOT LOT 508. ADDITIONAL INFORMATION - 2022-09-07. SIEMENS CONCLUDED THE INVESTIGATION FOR AN OUTSIDE OF THE UNITED STATES (OUS) CUSTOMER OBSERVATION OF FALSELY ELEVATED RESULTS WITH THE ATELLICA IM CA 19-9 ASSAY. THE CUSTOMER HAD SAMPLES FROM 2 PATIENTS WITH NO INDICATION OF CANCER THAT RECOVERED HIGHER WITH ATELLICA IM CA 19-9 LOT 506 THAN WITH OTHER MANUFACTURER'S CA 19-9 ASSAYS. WHEN THE SAMPLES WERE RETESTED WITH ATELLICA IM CA 19-9 LOT 508, THE RESULTS MATCHED THE KIT LOT 506 RESULTS SO THIS DOES NOT APPEAR TO BE A LOT SPECIFIC ISSUE. BIO-RAD CONTROLS WERE WITHIN THE NORMAL RANGES FOR CA19-9. THE CUSTOMER DILUTED THE SAMPLES AND TREATED THEM WITH PEG6000 AND NEITHER INDICATED THE PRESENCE OF AN INTERFERENT. THE CUSTOMER WAS NOT ABLE TO PROVIDE ANY KNOWN DISEASES FOR THE PATIENTS AND THE PATIENTS WERE NOT TAKING ANY MEDICATIONS/SUPPLEMENTS. THERE IS NO SAMPLE THAT CAN BE SENT TO SIEMENS HEALTHINEERS FOR EVALUATION. THE EXPECTED VALUES SECTION OF THE ATELLICA IM CA 19-9 INSTRUCTIONS FOR USE (IFU) (10995285) INDICATES THAT 3.7% OF SAMPLES FROM NORMAL PATIENTS RECOVERED >37 IU/ML, SO A CERTAIN NUMBER OF ELEVATED RESULTS FROM NORMAL PATIENTS CAN BE EXPECTED FOR THIS ASSAY. AS STATED IN THE LIMITATIONS SECTION OF THE ATELLICA IM CA 19-9 IFU: "DO NOT USE THE ATELLICA IM CA 19-9 ASSAY AS A SCREENING TEST OR FOR DIAGNOSIS. DO NOT PREDICT DISEASE RECURRENCE SOLELY ON LEVELS OF ATELLICA IM CA 19-9. NORMAL LEVELS OF ATELLICA IM CA 19-9 DO NOT ALWAYS PRECLUDE THE PRESENCE OF DISEASE.". "DO NOT INTERPRET SERUM LEVELS OF CA 19-9 AS ABSOLUTE EVIDENCE OF THE PRESENCE OR THE ABSENCE OF MALIGNANT DISEASE.". "THE CONCENTRATION OF CA 19-9 IN A GIVEN SPECIMEN, AS DETERMINED BY ASSAYS FROM DIFFERENT MANUFACTURERS, CAN VARY DUE TO DIFFERENCES IN ASSAY METHODS AND REAGENT SPECIFICITY.". THE CAUSE OF THE DISCREPANT RESULTS SEEN BY THE CUSTOMER WHEN USING ATELLICA IM CA 19-9 KIT LOTS 506 AND 508 COULD NOT BE DETERMINED, BUT SIEMENS CANNOT RULE OUT PRE-ANALYTICAL FACTORS, A SAMPLE ISSUE, OR NORMAL ASSAY PERFORMANCE. BASED ON THE INVESTIGATION, NO PRODUCT PROBLEM WAS IDENTIFIED. THE CUSTOMER IS OPERATIONAL. IN SECTION H6, INVESTIGATION FINDING AND INVESTIGATION CONCLUSION CODES WERE UPDATED BASED ON THE INVESTIGATION RESULTS.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED DISCORDANT (ELEVATED) RESULTS FOR 2 PATIENT SAMPLES WITH THE ATELLICA IM 1600 CA 19-9 ASSAY COMPARED TO ALTERNATE METHOD TESTING PLATFORMS. THE INITIAL RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). RETESTING WAS PERFORMED ON THE ATELLICA IM AND RESULTS WERE ALSO ELEVATED. THE SAMPLES WERE REMEASURED ON 2 ALTERNATE METHODS AND RESULTS WERE LOWER AND BELIEVED TO BE CORRECT AS THEY WERE IN AGREEMENT WITH EACH PATIENT'S CLINICAL HISTORY. ONE OF THE ALTERNATE METHOD RESULTS FOR EACH PATIENT WAS REPORTED AS CORRECT AND WAS ACCEPTED BY THE PHYSICIAN(S). THERE ARE NO REPORTS THAT TREATMENT WAS ALTERED OR PRESCRIBED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ELEVATED CA19-9 RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1348017 ATELLICA IM CA 19-9 (CA19-9) CARBOHYDRATE ANTIGEN (CA19-9) IMMUNOASSAY NIG SIEMENS HEALTHCARE DIAGNOSTICS, INC. N/A 506 00630414598161

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown