BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATELLICA IM 1600 ANALYZER

    MDR report key: 24483016 · Received March 2, 2026

    Report

    Report Number
    2432235-2026-00063
    Event Type
    Malfunction
    Date Received
    March 2, 2026
    Date of Event
    January 30, 2026
    Report Date
    February 27, 2026
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    JJE
    UDI-DI
    00630414002026
    PMA / PMN Number
    K151792
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN OUTSIDE OF THE UNITED STATES (OUS) CUSTOMER CONTACTED A SIEMENS CUSTOMER CARE CENTER TO REPORT FALSELY DEPRESSED CANCER ANTIGEN CA 19 9 (CA 19 9) RESULTS WERE OBTAINED ON A PATIENT SAMPLE ON ATELLICA IM 1600 ANALYZER. QUALITY CONTROLS (QCS) RECOVERED OUT OF RANGES ON THE DAY PRIOR AND THE DAY AFTER THE DATE OF THE EVENT. THE MILLIPORE QGUARD WAS CHANGED, A NEW CALIBRATION AND QC WERE PERFORMED AND WERE WITHIN ACCEPTABLE RANGES. SIEMENS INVESTIGATED THE EVENT AND REVIEWED THE CUSTOMERS BIO-RAD INTELIQ TUMOR MARKER QC LEVEL 3, WHICH SHOWED SOME IMPRECISION IN THE PACK-TO-PACK VARIABILITY. THE AUTOCHECK DATA FOR THE ANALYZER WAS REVIEWED AND WAS WITHIN ACCEPTABLE LIMITS BUT THE WATER PRESSURE WAS LOW WITHIN RANGE AND THE WASH PROBE VACUUM WAS HIGH WITH SEPARATION BETWEEN THE ASPIRATE PROBES. A SIEMENS CUSTOMER SERVICE ENGINEER (CSE) WAS DISPATCHED TO THE CUSTOMER¿S SITE. DURING THIS VISIT, THE CSE REPLACED THE VACUUM REGULATOR, WATER PRESSURE PUMP, WATER PRESSURE TRANSDUCER, SENSOR, WATER LINE PIPING, WASH PROBES, PINCH TUBES AND WASH RING MANIFOLD. THE CSE CALIBRATED THE VACUUM AND RECALIBRATED CA19-9 FOLLOWING SERVICE AND QC RECOVERED WITHIN RANGES. A 5-DAY PRECISION STUDY WAS CONDUCTED TO CONFIRM REPEATABILITY AND WITHIN-LABORATORY PRECISION ON THE ATELLICA IM ANALYZER USING MULTIPLE CA19-9 REAGENT LOTS. TESTING INCLUDED BIO-RAD LIQUICHEK TUMOR MARKER CONTROL LEVELS 1¿3 AS WELL AS THREE SERUM SAMPLES. ALL SAMPLES MET ACCEPTANCE CRITERIA FOR BOTH REPEATABILITY AND WITHIN-LAB PRECISION ACROSS ALL REAGENT LOTS. THESE RESULTS CONFIRM THAT THE PRECISION PERFORMANCE OF THE ATELLICA IM CA19-9 ASSAY REMAINS CONSISTENT WITH HISTORICAL EXPECTATIONS. SIEMENS FURTHER EVALUATED THE EVENT AND COULD NOT DETERMINE THE POTENTIAL CAUSE OF THE FALSELY DEPRESSED CA19-9 PATIENT RESULTS DUE TO THE REPLACEMENT AND SERVICING OF MULTIPLE PARTS WHICH IS CONSIDERED NORMAL TROUBLESHOOTING ACTIVITIES. THE INSTRUMENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THIS DEVICE IS REQUIRED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED FALSELY DEPRESSED CANCER ANTIGEN CA 19 9 (CA 19 9) RESULTS WERE OBTAINED ON A PATIENT SAMPLE ON AN ATELLICA IM 1600 ANALYZER. THE ERRONEOUS RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLE WAS REPEATED ON AN ALTERNATE ATELLICA IM ANALYZER. THE REPEAT RESULT WAS HIGHER THAN THE ERRONEOUS RESULTS. THE REPEAT RESULT FROM THE INITIAL ATELLICA IM ANALYZER WAS REPORTED, AS THE CORRECT RESULT TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY DEPRESSED CA 19-9 RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    546967 ATELLICA IM 1600 ANALYZER ATELLICA IM 1600 ANALYZER JJE SIEMENS HEALTHCARE DIAGNOSTICS INC. ATELLICA IM 1600 ANALYZER 00630414002026

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Female