BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS ANTI-CCP

    MDR report key: 19927573 · Received August 7, 2024

    Report

    Report Number
    1823260-2024-02288
    Event Type
    Malfunction
    Date Received
    August 7, 2024
    Date of Event
    October 8, 2020
    Report Date
    September 18, 2024
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    NHX
    UDI-DI
    04015630940370
    PMA / PMN Number
    K081338
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE SERIAL NUMBER OF THE E 801 ANALYZER IS (B)(6) . THE SERIAL NUMBER OF THE SECOND E 801 ANALYZER WAS REQUESTED, BUT NOT PROVIDED. A SAMPLE FROM THE PATIENT WAS PROVIDED FOR INVESTIGATION. AN INTERFERING FACTOR AGAINST THE STREPTAVIDIN COMPONENT OF THE ELECSYS ANTI-CCP ASSAY WAS RULED OUT. THE INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 0

    ON (B)(6) 2022, THE PATIENT HAD AN RF RESULT OF 11.3 IU/ML (NEGATIVE). ON (B)(6) 2023, THE PATIENT HAD AN RF IGG RESULT OF 1 U/ML (NEGATIVE), AN RF IGA RESULT OF 1 U/ML (NEGATIVE), AND AN RF IGM RESULT OF 4 U/ML (NEGATIVE). INVESTIGATIONS OF THE PATIENT SAMPLE WERE ABLE TO RULE OUT OTHER HETEROPHILIC ANTIBODY INTERFERENCE. FURTHER CLARIFICATION OF THE OBSERVED DISCREPANCIES IS NOT POSSIBLE WITH AVAILABLE METHODS AND THE CURRENT STATE OF THE ART. THE INVESTIGATION COULD NOT IDENTIFY A PRODUCT ISSUE.

    Description of Event or Problem · 0

    THE INITIAL REPORTER STATED THEY RECEIVED QUESTIONABLE RESULTS FOR 8 SAMPLES FROM THE SAME PATIENT TESTED WITH ELECSYS ANTI-CCP ON A COBAS E 801 ANALYTICAL UNIT. THE EIGHTH SAMPLE WAS ALSO TESTED ON A SECOND E 801 UNIT. THE ELECSYS ANTI-CCP RESULTS WERE ALL HIGH (REFERENCE RANGE = < 17 U/ML), BUT THE PATIENT HAD NO CLINICAL SYMPTOMS. THE FIRST SAMPLE RESULTED IN AN ANTI-CCP VALUE OF 108 U/ML. THE SECOND SAMPLE RESULTED IN AN ANTI-CCP VALUE OF 193 U/ML ON (B)(6) 2022. THE THIRD SAMPLE RESULTED IN AN ANTI-CCP VALUE OF 216 U/ML ON (B)(6) 2022. THE FOURTH SAMPLE RESULTED IN AN ANTI-CCP VALUE OF 185 U/ML ON (B)(6) 2023. THE FIFTH SAMPLE RESULTED IN AN ANTI-CCP VALUE OF 184 U/ML ON (B)(6) 2023. THE SIXTH SAMPLE RESULTED IN AN ANTI-CCP VALUE OF 172 U/ML ON (B)(6) 2023. THE SEVENTH SAMPLE RESULTED IN AN ANTI-CCP VALUE OF 184 U/ML ON (B)(6) 2023. THE EIGHTH SAMPLE INITIALLY RESULTED IN AN ANTI-CCP VALUE OF 162 U/ML ON (B)(6) 2024. THIS SAMPLE WAS REPEATED ON THE SAME E 801 SYSTEM, RESULTING IN A VALUE OF 184 U/ML. IT WAS ALSO REPEATED ON A SECOND E 801 ANALYZER, RESULTING IN A VALUE OF 187 U/ML. THE PATIENT WAS TESTED AT THREE OTHER HOSPITALS USING THE EUROIMMUN ANTI-CCP METHOD AND TWO UNKNOWN METHODS. ANTI-CCP RESULTS FOR ALL OTHER METHODS WERE NEGATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    234446 ELECSYS ANTI-CCP ANTIBODIES, ANTI-CYCLIC CITRULLINATED PEPTIDE (CCP) NHX ROCHE DIAGNOSTICS ASKU 04015630940370

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown