BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS ANTI-CCP IMMUNOASSAY

    MDR report key: 10647700 · Received October 8, 2020

    Report

    Report Number
    1823260-2020-02486
    Event Type
    Malfunction
    Date Received
    October 8, 2020
    Date of Event
    September 18, 2020
    Report Date
    December 3, 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 INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED. NO INTERFERING FACTOR WAS DETECTED IN THE SAMPLE. PRODUCT LABELING FOR THE ASSAY STATES "THE MEASURED ANTI CCP VALUE OF A PATIENT¿S SAMPLE CAN VARY DEPENDING ON THE TESTING PROCEDURE USED. THE LABORATORY FINDING MUST THEREFORE ALWAYS CONTAIN A STATEMENT ON THE ANTI CCP ASSAY METHOD USED. 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."

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS ONGOING. THIS EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    THE INITIAL REPORTER RECEIVED QUESTIONABLE HIGH ELECSYS ANTI-CCP IMMUNOASSAY RESULTS FOR AN UNKNOWN NUMBER OF PATIENT SAMPLES FROM A COBAS 6000 E601 MODULE. ONE EXAMPLE WAS PROVIDED OF A PATIENT WITH AN ELECSYS ANTI-CCP RESULT OF 66 U/ML WHEREAS WITH COMPETITOR ASSAYS, THE ANTI-CCP-ABS, AS WELL AS ANTI-MCV-ABS RESULTS, WERE NEGATIVE. THE CLINICAL EXPECTATION WAS A NEGATIVE RESULT FOR ANTI-CCP. IT WAS REQUESTED, BUT IT WAS NOT KNOWN IF ANY QUESTIONABLE RESULT WAS REPORTED OUTSIDE OF THE LABORATORY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1113014 ELECSYS ANTI-CCP IMMUNOASSAY ANTIBODIES, ANTI-CYCLIC CITRULLINATED PEPTIDE (CCP) NHX ROCHE DIAGNOSTICS NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1