BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS ANTI-CCP

    MDR report key: 23125394 · Received September 23, 2025

    Report

    Report Number
    1823260-2025-03497
    Event Type
    Malfunction
    Date Received
    September 23, 2025
    Date of Event
    August 1, 2025
    Report Date
    February 12, 2026
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    NHX
    PMA / PMN Number
    K081338
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE ANALYZER SERIAL NUMBER IS (B)(6). THE PATIENT SAMPLES WERE REQUESTED FOR INVESTIGATION. THE INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 0

    IN THE INITIAL MDR'S B5 DESCRIBE EVENT OR PROBLEM, THE LINES "THE SAMPLE WAS REPEATED ON A COMPETITOR ANALYZER AND THE RESULT WAS NEGATIVE." SHOULD HAVE BEEN: "THE SAMPLE WAS REPEATED ON A COMPETITOR ANALYZER THAT USES THE ENZYME-LINKED IMMUNOSORBENT ASSAY (ELISA), AND THE RESULT WAS NEGATIVE." THE CUSTOMER STATED THAT THE POSITIVE ELECSYS ANTI-CCP RESULTS DID NOT FIT THE CLINICAL PICTURE. ON (B)(6) 2025, THE CUSTOMER PROVIDED NEW ELECSYS ANTI-CCP REPEAT RESULTS FOR THE FOLLOWING PREVIOUSLY REPORTED PATIENT SAMPLES. THE LABORATORY METHOD AND UNIT OF MEASUREMENT WERE NOT PROVIDED. FOR SAMPLE 3, THE INITIAL RESULT WAS 68.3 U/ML. THE SAMPLE WAS REPEATED ON A COMPETITOR ANALYZER, AND THE RESULT WAS NEGATIVE. ON (B)(6) 2025, THE REPEAT RESULT WAS 32.5. FOR SAMPLE 4, THE INITIAL RESULT WAS 45.9 U/ML. THE SAMPLE WAS REPEATED ON A COMPETITOR ANALYZER, AND THE RESULT WAS NEGATIVE. ON (B)(6) 2025, THE REPEAT RESULT WAS 26.5. FOR SAMPLE 5, THE INITIAL RESULT WAS 46 U/ML. THE SAMPLE WAS REPEATED ON A COMPETITOR ANALYZER, AND THE RESULT WAS NEGATIVE. ON (B)(6) 2025, THE REPEAT RESULT WAS 21.8. ON (B)(6) 2025, THE CUSTOMER PROVIDED SIX NEW QUESTIONABLE ELECSYS ANTI-CCP RESULTS. THE LABORATORY METHOD AND UNIT OF MEASUREMENT WERE NOT PROVIDED. FOR SAMPLE 6, THE INITIAL RESULT WAS 65 U/ML. ON (B)(6) 2025, THE REPEAT RESULT WAS 26.9. FOR SAMPLE 7, THE INITIAL RESULT WAS 63.6 U/ML. ON (B)(6) 2025, THE REPEAT RESULT WAS 28.7. FOR SAMPLE 8, THE INITIAL RESULT WAS 53.2 U/ML. ON (B)(6) 2025, THE REPEAT RESULT WAS 52.3. FOR SAMPLE 9, THE INITIAL RESULT WAS 189 U/ML. ON (B)(6) 2025, THE REPEAT RESULT WAS 35.3. FOR SAMPLE 10, THE INITIAL RESULT WAS 67.5 U/ML. ON (B)(6) 2025, THE REPEAT RESULT WAS 24.2. FOR SAMPLE 11, THE INITIAL RESULT WAS 76.9 U/ML. ON (B)(6) 2025, THE REPEAT RESULT WAS 27.3. THE SAMPLES WERE RECEIVED FOR INVESTIGATION AND WERE TESTED FOR THE PRESENCE OF INTERFERENTS. FOR SIX OF THE PATIENT SAMPLES, THE INVESTIGATION DETERMINED THAT THE EVENT WAS CONSISTENT WITH A STREPTAVIDIN INTERFERENT IN THE PATIENT SAMPLES. FOR FIVE OF THE PATIENT SAMPLES, THE INVESTIGATION CONFIRMED THE CUSTOMER¿S ELECSYS ANTI-CCP RESULTS. HOWEVER, THE CAUSE OF THE EVENT COULD NOT BE DETERMINED. PER PRODUCT LABELING: "IN RARE CASES, INTERFERENCE DUE TO EXTREMELY HIGH TITERS OF ANTIBODIES TO ANALYTE-SPECIFIC ANTIBODIES, STREPTAVIDIN OR RUTHENIUM CAN OCCUR. FOR DIAGNOSTIC PURPOSES, THE RESULTS SHOULD ALWAYS BE ASSESSED IN CONJUNCTION WITH THE PATIENT'S MEDICAL HISTORY, CLINICAL EXAMINATION AND OTHER FINDINGS." THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM.

    Description of Event or Problem · 0

    THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS ANTI-CCP RESULTS FOR 5 PATIENT SAMPLES ON A COBAS E 801 ANALYTICAL UNIT. THE DOCTOR STATED THAT THE RESULTS DO NOT MATCH THE CLINICAL STATUS OF THE PATIENTS. FOR SAMPLE 1, THE INITIAL RESULT WAS 91.6 U/ML. THE SAMPLE WAS REPEATED ON A COMPETITOR ANALYZER AND THE RESULT WAS NEGATIVE. FOR SAMPLE 2, THE INITIAL RESULT WAS 157 U/ML. THE SAMPLE WAS REPEATED ON A COMPETITOR ANALYZER AND THE RESULT WAS NEGATIVE. FOR SAMPLE 3, THE INITIAL RESULT WAS 68.3 U/ML. THE SAMPLE WAS REPEATED ON A COMPETITOR ANALYZER AND THE RESULT WAS NEGATIVE. FOR SAMPLE 4, THE INITIAL RESULT WAS 45.9 U/ML. THE SAMPLE WAS REPEATED ON A COMPETITOR ANALYZER AND THE RESULT WAS NEGATIVE. FOR SAMPLE 5, THE INITIAL RESULT WAS 46 U/ML. THE SAMPLE WAS REPEATED ON A COMPETITOR ANALYZER AND THE RESULT WAS NEGATIVE. THE EXACT DATES OF TESTING WERE NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    733995 ELECSYS ANTI-CCP ANTIBODIES, ANTI-CYCLIC CITRULLINATED PEPTIDE (CCP) NHX ROCHE DIAGNOSTICS 860040

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male