BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS ANTI-CCP

    MDR report key: 19851638 · Received July 29, 2024

    Report

    Report Number
    1823260-2024-02189
    Event Type
    Malfunction
    Date Received
    July 29, 2024
    Date of Event
    May 29, 2024
    Report Date
    December 13, 2024
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    NHX
    PMA / PMN Number
    K081338
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE ANALYZER SERIAL NUMBER IS (B)(6). THE PATIENT SAMPLE WAS REQUESTED FOR INVESTIGATION. THE INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 0

    MULTIPLE SAMPLES FROM THE PATIENT WERE SUBMITTED FOR INVESTIGATION. FOR SOME OF THE SAMPLES, AN INTERFERENCE WITH THE STREPTAVIDIN COMPONENT OF THE ASSAY WAS FOUND. FOR OTHERS, THE RESULT INDICATED A BORDERLINE INTERFERENCE. PER PRODUCT LABELING FOR THE ASSAY: IN RARE CASES, INTERFERENCE DUE TO EXTREMELY HIGH TITERS OF ANTIBODIES TO ANALYTE-SPECIFIC ANTIBODIES, STREPTAVIDIN OR RUTHENIUM CAN OCCUR. THESE EFFECTS ARE MINIMIZED BY SUITABLE TEST DESIGN. FOR DIAGNOSTIC PURPOSES, THE RESULTS SHOULD ALWAYS BE ASSESSED IN CONJUNCTION WITH THE PATIENT¿S MEDICAL HISTORY, CLINICAL EXAMINATION, AND OTHER FINDINGS.

    Description of Event or Problem · 0

    THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS ANTI-CCP RESULTS FOR 1 PATIENT ON A COBAS E 801 ANALYTICAL UNIT. ON (B)(6) 2024, THE PATIENT HAD AN ANTI-CCP RESULT OF 145 U/ML. THE CUSTOMER LATER HAD ANOTHER SAMPLE COLLECTED AND TESTED AT ANOTHER LABORATORY WHERE THE ANTI-CCP RESULT WAS NORMAL, WHICH MADE THE PATIENT QUESTION THE INITIAL RESULT. ON (B)(6) 2024, THE SAMPLE FROM 29-MAY WAS RETESTED AND THE RESULT WAS 111 U/ML. THE SAMPLE WAS ALSO SENT TO ANOTHER LABORATORY FOR ELISA IMMUNOBLOT TESTING AND THE ANTI-CCP RESULT WAS 13.16 IU/ML. CLARIFICATION ON THE CORRECT UNITS OF MEASUREMENT WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    399402 ELECSYS ANTI-CCP ANTIBODIES, ANTI-CYCLIC CITRULLINATED PEPTIDE (CCP) NHX ROCHE DIAGNOSTICS 76643201

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Male