BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS ANTI-CCP

    MDR report key: 17379317 · Received July 24, 2023

    Report

    Report Number
    1823260-2023-02417
    Event Type
    Malfunction
    Date Received
    July 24, 2023
    Date of Event
    April 26, 2023
    Report Date
    September 5, 2023
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    NHX
    PMA / PMN Number
    K081338
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE MEDICAL DEVICE PROBLEM CODE WAS UPDATED. THE CUSTOMER SENT AN ALIQUOT OF THE SAMPLE FROM 03-JUL-2023 TO A DIFFERENT LABORATORY WHERE THE ANTI-CCP RESULT FROM AN UNKNOWN METHOD WAS REPRODUCIBLE TO THE CUSTOMER'S RESULT. CALIBRATION WAS LAST PERFORMED ON 30-JUN-2023 WITH ACCEPTABLE RESULTS. QC WAS ACCEPTABLE. THERE WAS NO SUGGESTION OF A REAGENT PROBLEM. THE CUSTOMER USED 13 MM SAMPLE TUBES WITH NO SAMPLE DISK TUBE ADAPTER (SDTA). PRODUCT LABELING STATES: "NOT USING A 13 MM SDTA WITH 13 MM TUBES OR INCORRECT USE OF A 13 MM SDTA MAY CAUSE INCORRECT RESULTS OR ERRORS. ALWAYS USE 13 MM SDTAS WITH 13 MM TUBES." NO ISSUES WERE IDENTIFIED DURING A REVIEW OF THE ALARM TRACE DATA. THE FIELD APPLICATION SPECIALIST (FAS) PERFORMED PRECISION TESTING WITH ACCEPTABLE RESULTS. SAMPLE MATERIAL FROM THE PATIENT WAS NO LONGER AVAILABLE FOR THE INVESTIGATION. BASED ON THE INFORMATION AVAILABLE, THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 0

    THE E411 ANALYZER SERIAL NUMBER WAS (B)(6). PRODUCT LABELING 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. THEREFORE, THE RESULTS REPORTED BY THE LABORATORY TO THE PHYSICIAN SHOULD INCLUDE: "THE FOLLOWING RESULTS WERE OBTAINED WITH THE ELECSYS ANTI-CCP ASSAY. RESULTS FROM ASSAYS OF OTHER MANUFACTURERS CANNOT BE USED INTERCHANGEABLY." SAMPLE MATERIAL WAS REQUESTED FOR INVESTIGATION.

    Description of Event or Problem · 0

    THE INITIAL REPORTER QUESTIONED HIGH RESULTS NOT CORRESPONDING TO THE CLINICAL PICTURE FOR 1 PATIENT TESTED FOR ELECSYS ANTI-CCP (ANTI-CCP) ON A COBAS E 411 IMMUNOASSAY ANALYZER. ON (B)(6) 2023 THE PATIENT HAD AN ANTI-CCP RESULT FROM THE E411 ANALYZER OF 181 U/ML (POSITIVE). DUE TO THIS RESULT, THE PATIENT WENT TO A DIFFERENT LABORATORY FOR TESTING. DATA WAS PROVIDED SHOWING A RESULT FROM (B)(6) 2023 FROM AN EXTERNAL LABORATORY USING AN UNSPECIFIED ENZYME-LINKED IMMUNOSORBENT ASSAY (ELISA) OF 0.70 U/ML (NEGATIVE). ON (B)(6)2023 THE ANTI-CCP RESULT FROM THE E411 ANALYZER WAS 202 U/ML (POSITIVE). THE REPEAT RESULT WAS 210.1 U/ML WITH A DATA FLAG (POSITIVE). THE CUSTOMER SENT THE SAMPLE FROM (B)(6)2023 TO AN EXTERNAL LABORATORY WHERE THE ANTI-CCP RESULT FROM AN UNSPECIFIED ENZYME IMMUNOASSAY (EIA) METHOD WAS 2.0 RU/ML (NEGATIVE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    947635 ELECSYS ANTI-CCP ANTIBODIES, ANTI-CYCLIC CITRULLINATED PEPTIDE (CCP) NHX ROCHE DIAGNOSTICS NA 690235

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Male