BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS ANTI-CCP

    MDR report key: 23707771 · Received December 3, 2025

    Report

    Report Number
    1823260-2025-04936
    Event Type
    Malfunction
    Date Received
    December 3, 2025
    Date of Event
    November 13, 2025
    Report Date
    December 18, 2025
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    NHX
    PMA / PMN Number
    K081338
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION DETERMINED THE ISSUE IS CONSISTENT WITH HEMOLYSIS OF THE PATIENT SAMPLE. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT ISSUE.

    Additional Manufacturer Narrative · 0

    THE SERIAL NUMBER OF THE E411 ANALYZER WAS (B)(6). THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 0

    THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH ELECSYS ANTI-CCP ON A COBAS E411 RACK. THE SAMPLE INITIALLY RESULTED IN AN ANTI-CCP VALUE OF 50 U/ML. THE SAMPLE WAS DILUTED X 5 USING LOW CONCENTRATION PATIENT SERUM AND REPEATED, RESULTING IN AN ANTI-CCP VALUE OF 660 U/ML.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2787445 ELECSYS ANTI-CCP ANTIBODIES, ANTI-CYCLIC CITRULLINATED PEPTIDE (CCP) NHX ROCHE DIAGNOSTICS ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown