BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS ANTI-CCP IMMUNOASSAY

    MDR report key: 7955597 · Received October 11, 2018

    Report

    Report Number
    1823260-2018-03560
    Event Type
    Malfunction
    Date Received
    October 11, 2018
    Date of Event
    September 19, 2018
    Report Date
    November 5, 2018
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    NHX
    PMA / PMN Number
    K081338
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    CALIBRATION DATA AND QC DATA ARE WITHIN EXPECTATIONS. A GENERAL REAGENT ISSUE MOST LIKELY CAN BE EXCLUDED. THE DETECTION OF ANTI-CCP ANTIBODIES IS PERFORMED WITH A MIXTURE OF VARIOUS CCP'S. AS DIFFERENT METHODS USE DIFFERENT MIXTURES INCLUDING DIFFERENT (AMOUNTS) OF THESE PEPTIDES, IT IS VERY LIKELY THAT SPECIFICITY BETWEEN METHODS DIFFERS. THIS IS NOTED IN THE PRODUCT LABELING. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    THE CUSTOMER COMPLAINED OF A DISCREPANT ELECSYS ANTI-CCP IMMUNOASSAY RESULT FOR 1 PATIENT SAMPLE ON COBAS 8000 E 602 MODULE SERIAL NUMBER (B)(4). THE PATIENT HAD GONE TO THE RHEUMATOLOGIST FOR PAIN. THE INITIAL ANTI-CCP RESULT WAS 213.3 U/L ON THE E 602 MODULE. THE PHYSICIAN QUESTIONED THE RESULT AND THE SAMPLE WAS SENT TO ANOTHER LABORATORY. THE ANTI-CCP RESULT WAS NEGATIVE WITH THE PHARMACIA IMMUNOCAP METHOD. THE ANTI-CCP RESULT WAS 0 U/L WITH THE EURO DIAGNOSTICA ELISA METHOD. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE RHEUMATOLOGIST STATED THAT PATIENTS' ANTI-CCP RESULTS ARE OFTEN POSITIVE WITH ROCHE TESTS AND NEGATIVE WITH OTHER METHODS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    796461 ELECSYS ANTI-CCP IMMUNOASSAY ANTIBODIES, ANTI-CYCLIC CITRULLINATED PEPTIDE (CCP) NHX ROCHE DIAGNOSTICS NA 34774000

    Patients

    Seq Age Sex Outcome Treatment
    1