BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROTEIN C REAGENT

    MDR report key: 23766735 · Received December 10, 2025

    Report

    Report Number
    9610806-2025-00054
    Event Type
    Malfunction
    Date Received
    December 10, 2025
    Date of Event
    November 6, 2025
    Report Date
    January 12, 2026
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH
    Product Code
    GGP
    UDI-DI
    00842768008641
    PMA / PMN Number
    K002541
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN OUTSIDE OF THE UNITED STATES (OUS) CUSTOMER CONTACTED SIEMENS CUSTOMER CARE CENTER TO REPORT DISCORDANT RESULTS THAT WERE OBTAINED ON ONE PATIENT SAMPLE ON THE CN-6000 INSTRUMENT. SIEMENS IS INVESTIGATING.

    Additional Manufacturer Narrative · 0

    SIEMENS FILED THE INITIAL MDR 9610806-2025-00054 ON 10-DEC-2025. ADDITIONAL INFORMATION RECEIVED 19-DEC-2025: SIEMENS REVIEWED THE INFORMATION PROVIDED AND DATA OBTAINED. THE DIFFERENCES IN RESULTS LIKELY STEM FROM MULTIPLE FACTORS, INCLUDING VARIATIONS IN METHODOLOGY, CALIBRATION, AND REFERENCE RANGES, WHICH CAN AFFECT BOTH VALUES AND INTERPRETATION. FOR INSTANCE, A RECENT THROMBOTIC EVENT COULD EXPLAIN DECREASED PROTEIN C ACTIVITY, BUT THE ORIGINAL DATA SUGGESTS THIS ALONE MAY NOT ACCOUNT FOR THE REDUCTION, POSSIBLY INDICATING A DEFICIENCY THAT REQUIRES FURTHER INVESTIGATION. QUALITY CONTROL DATA SHOW ALL LEVELS WITHIN ACCEPTABLE LIMITS, CONFIRMING THE INSTRUMENT IS FUNCTIONING PROPERLY. THEREFORE, THE OBSERVED DIFFERENCES ARE MOST LIKELY DUE TO ASSAY PRINCIPLES (SIEMENS VS. ALTERNATE METHOD) AND REAGENT VARIABILITY. BASED ON THE AVAILABLE INFORMATION, A SINGLE ROOT CAUSE CANNOT BE DEFINITIVELY ASSIGNED. THE MOST PLAUSIBLE EXPLANATION REMAINS METHODOLOGICAL AND REAGENT DIFFERENCES BETWEEN THE SIEMENS AND ALTERNATE SYSTEMS, RATHER THAN AN ANALYTICAL ERROR. ASSESSMENT OF INSTRUMENT PERFORMANCE INCLUDED A REVIEW OF QC (QUALITY CONTROL) RESULTS HAVE BEEN FOUND WITHIN RANGE ON THE COMPLAINED DAY NO HARDWARE OR SOFTWARE ERRORS COULD BE FOUND IN THE LOGS CALIBRATION CURVE WAS CHECKED, WHICH LOOKS INCONSPICUOUS SAMPLE RESULTS WERE UNFLAGGED. REAGENT ISSUES WERE RULED OUT BASED ON REVIEW OF QC WHICH SHOWED RECOVERY WITHIN ACCEPTABLE RANGES. CUSTOMER IS OPERATIONAL, SYSTEM WORKS AS SPECIFIED. IN SECTION H6, THE INVESTIGATION FINDINGS AND INVESTIGATION CONCLUSIONS CODES WERE UPDATED. THE REPORTED BEHAVIOR WAS RESOLVED BY STANDARD SERVICE ACTIONS/ROUTINE TROUBLESHOOTING THE INSTRUMENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THIS DEVICE IS REQUIRED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THE OBSERVATION OF A FALSELY DEPRESSED PROTEIN C RESULT OBTAINED ON ONE PATIENT SAMPLE MEASURED WITH PROTEIN C REAGENT ON THE CN-6000 INSTRUMENT COMPARED TO AN ALTERNATE METHOD. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1990548 PROTEIN C REAGENT TEST, QUALITATIVE AND QUANTITATIVE FACTOR DEFICIENCY GGP SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH 03234 00842768008641

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Female