BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS ANTI-CCP IMMUNOASSAY

    MDR report key: 9922628 · Received April 3, 2020

    Report

    Report Number
    1823260-2020-00952
    Event Type
    Malfunction
    Date Received
    April 3, 2020
    Date of Event
    February 4, 2020
    Report Date
    April 29, 2020
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    NHX
    PMA / PMN Number
    K081338
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE PATIENT'S SAMPLE WAS SENT TO THE MANUFACTURER FOR INVESTIGATION. NO INTERFERING FACTOR COULD BE DETECTED IN THE SAMPLE. THE MEASURED AUTOANTIBODIES IN A PATIENT¿S SAMPLE CAN VARY DEPENDING ON THE TESTING PROCEDURE USED. AUTOANTIBODY VALUES MEASURED IN PATIENT SAMPLES BY DIFFERENT TESTING PROCEDURES CANNOT BE DIRECTLY COMPARED. ELECSYS® ANTI-CCP IS A SECOND GENERATION ANTI-CCP ASSAY. MORE THAN ONE CYCLIC CITRULLINATED PEPTIDE IS USED. IN THIS ASSAY, FOUR DIFFERENT ARTIFICIAL CYCLIC CITRULLINATED PEPTIDES ARE USED. THE AMOUNT OF GIVEN CYCLIC CITRULLINATED PEPTIDES IN THE ELECSYS® ASSAY MAY LEAD TO A HIGHER SENSITIVITY. REACTIVITY OF AUTOANTIBODIES IN DIFFERENT TESTS VARY, BECAUSE OF THE USE OF DIFFERENT ASSAY FORMATS, ASSAY REAGENTS, DETECTION ANTIBODIES, ANTIGEN FORMULATIONS AND INCUBATION TIMES. PRODUCT LABELING STATES, "ANTI-CCP VALUES DETERMINED ON PATIENT SAMPLES BY DIFFERENT TESTING PROCEDURES CANNOT BE DIRECTLY COMPARED WITH ONE ANOTHER AND COULD BE THE CAUSE OF ERRONEOUS MEDICAL INTERPRETATIONS." THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    THE COUNTRY OF ORIGIN IS (B)(6). THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 1

    THE INITIAL REPORTER RECEIVED A QUESTIONABLE ELECSYS ANTI-CCP IMMUNOASSAY RESULT FROM THE COBAS 8000 E 801 MODULE SERIAL NUMBER (B)(4). THE INITIAL RESULT WAS 142 U/ML WHICH WAS NOT BELIEVED TO BE CORRECT BECAUSE IT DID NOT MATCH THE CLINICAL EXPECTATION. THE CLINICAL EXPECTATION IS NORMAL VALUES FOR ANTI-CCP. THE RESULT FROM THE IMMUNOCAP FROM THERMOFISHER WAS 1.8 U/ML AND THE RESULT FROM THE ABBOTT WAS 2 U/ML. BOTH RESULTS WERE NORMAL VALUES FOR ANTI-CCP. IT WAS NOTED THAT DUE TO HIGH ROCHE VALUES A " PREDNISOLON AND MTX" THERAPY WAS INITIATED. THE QUESTIONABLE RESULT WAS REPORTED OUTSIDE THE LABORATORY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    387045 ELECSYS ANTI-CCP IMMUNOASSAY ANTIBODIES, ANTI-CYCLIC CITRULLINATED PEPTIDE (CCP) NHX ROCHE DIAGNOSTICS NA 46191301

    Patients

    Seq Age Sex Outcome Treatment
    1 L-THYROXIN| MTX| PREDNISOLON