BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS ANTI-CCP IMMUNOASSAY

    MDR report key: 8640162 · Received May 24, 2019

    Report

    Report Number
    1823260-2019-01942
    Event Type
    Malfunction
    Date Received
    May 24, 2019
    Date of Event
    April 17, 2019
    Report Date
    September 5, 2019
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    NHX
    PMA / PMN Number
    K081338
    Removal / Correction Number
    1823260-07/16/19-007-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING INFORMATION HAS BEEN COMMUNICATED TO ROCHE CUSTOMERS: ROCHE HAS CONFIRMED PERFORMANCE ISSUES WITH CERTAIN LOTS OF THE ELECSYS ANTI-CCP ASSAY ON THE COBAS E 411 ANALYZER; MODULAR ANALYTICS E 170 MODULE; AND COBAS E 601, 602, AND 801 MODULES WITH PLASMA SAMPLES. THE FOLLOWING CUSTOMER OBSERVATIONS HAVE BEEN REPORTED: 1. DISCREPANT RESULTS BETWEEN SERUM AND PLASMA SAMPLES FROM THE SAME BLOOD DRAW OF A GIVEN PATIENT: NEGATIVE RESULTS (< CUTOFF) ON SERUM AND POSITIVE RESULTS ON PLASMA SAMPLES. 2. DISCREPANT CONCENTRATIONS OBTAINED ON PLASMA SAMPLES WHEN COMPARING DIFFERENT REAGENT LOTS. SERUM SAMPLES ARE NOT AFFECTED AND DO NOT REQUIRE A WORKAROUND. IT IS STRONGLY ADVISED TO USE THE ELECSYS ANTI-CCP ASSAY WITH SERUM SAMPLES ONLY FOR THE AFFECTED LOTS. ROCHE IS CONDUCTING AN INVESTIGATION INTO THE REPORTED ISSUE AND HAS DETERMINED THAT THE ELECSYS ANTI-CCP ASSAY IS STRONGLY AFFECTED BY PRE-ANALYTICAL ERRORS. THE INVESTIGATION HAS REPRODUCED THESE FINDINGS WHEN REQUIREMENTS FOR PRE-ANALYTICAL SAMPLE HANDLING HAVE NOT BEEN MET FOR PLASMA SAMPLES. THEREFORE, WE WOULD LIKE TO EMPHASIZE THE IMPORTANCE OF FOLLOWING THE PRE-ANALYTICAL SAMPLE HANDLING RECOMMENDATIONS WHEN PROCESSING SAMPLES (SERUM AND PLASMA).

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6). THE CUSTOMER SUBMITTED 7 PATIENT SAMPLES FOR INVESTIGATION. THE SAMPLES WERE TESTED WITH ANTI-CCP REAGENT LOTS 389152 AND 400794 ON AN E602 MODULE AT THE INVESTIGATION SITE. THE INVESTIGATION WAS ABLE TO REPRODUCE THE CUSTOMER'S ISSUE. SIX OF THE SEVEN PATIENT SAMPLES SHOWED HIGHER RESULTS WITH REAGENT LOT 389152 COMPARED TO REAGENT LOT 400794.

    Description of Event or Problem · 1

    THE INITIAL REPORTER COMPLAINED OF A HIGH FREQUENCY OF POSITIVE RESULTS FOR PATIENTS TESTED FOR ELECSYS ANTI-CCP IMMUNOASSAY (ANTI-CCP) ON A COBAS 8000 E 602 MODULE. THE CUSTOMER NOTICED THE ELEVATED FREQUENCY OF POSITIVE RESULTS IN THE RANGE OF 40 - 60 U/ML SINCE BEGINNING TO USE ANTI-CCP REAGENT LOT 389152. THE CUSTOMER PROVIDED EXAMPLES FOR 3 PATIENT SAMPLES: PATIENT 1 HAD A RESULT OF 42 U/ML ON THE E602 MODULE. ON (B)(6) 2019 PATIENT 2 (FEMALE WITH DATE OF BIRTH OF (B)(6)) HAD A RESULT OF 48 U/ML ON THE E602 MODULE. ON (B)(6) 2019 PATIENT 3 (MALE WITH A DATE OF BIRTH OF (B)(6)) HAD A RESULT OF 51 U/ML ON THE E602 MODULE. THE INITIAL RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY WHERE REPEAT TESTING WAS REQUESTED. THE 3 PATIENT SAMPLES WERE REPEATED ON THE E602 MODULE AND THE RESULTS WERE REPRODUCIBLE. THE 3 PATIENT SAMPLES WERE REPEATED IN AN EXTERNAL LABORATORY USING THE ABBOTT ARCHITECT METHOD AND THE RESULTS FOR ALL 3 PATIENT SAMPLES WERE < 10 U/ML. THERE WAS NO ALLEGATION THAT AN ADVERSE EVENT OCCURRED. THE E602 MODULE SERIAL NUMBER WAS (B)(4). INVESTIGATIONS ARE ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    434709 ELECSYS ANTI-CCP IMMUNOASSAY ANTIBODIES, ANTI-CYCLIC CITRULLINATED PEPTIDE (CCP) NHX ROCHE DIAGNOSTICS NA 38915201

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR