BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANTI-CCP

    MDR report key: 5018159 · Received August 20, 2015

    Report

    Report Number
    1823260-2015-03994
    Event Type
    Malfunction
    Date Received
    August 20, 2015
    Date of Event
    July 16, 2015
    Report Date
    September 2, 2015
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    NHX
    PMA / PMN Number
    K081338
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6).

    Additional Manufacturer Narrative · 1

    THE PATIENT SAMPLES WERE NOT PROVIDED TO COMPLETE THE INVESTIGATION.

    Description of Event or Problem · 1

    THE CUSTOMER COMPLAINED OF ERRONEOUS RESULTS FOR 2 PATIENT SAMPLES TESTED FOR ANTI-CCP. THE ERRONEOUS RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. PATIENT 1 INITIAL ANTI-CCP RESULT WAS 128 U/ML. THE REPEAT RESULTS FROM AN ABBOTT ANALYZER AND A PHADIA ANALYZER WERE BOTH "NEGATIVE." THE ACTUAL RESULTS WERE NOT PROVIDED. PATIENT 2 (FEMALE WITH (B)(6)) INITIAL ANTI-CCP RESULT WAS 188 U/ML. THE REPEAT RESULTS FROM AN ABBOTT ANALYZER AND A PHADIA ANALYZER WERE BOTH "NEGATIVE." THE ACTUAL RESULTS WERE NOT PROVIDED. NO ADVERSE EVENT WAS REPORTED. THE E602 ANALYZER SERIAL NUMBER WAS (B)(4). A SPECIFIC ROOT CAUSE COULD NOT BE IDENTIFIED. ADDITIONAL INFORMATION FOR FURTHER INVESTIGATION WAS REQUESTED BUT WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    552554 ANTI-CCP ANTIBODIES, ANTI-CYCLIC CITRULLINATED PEPTIDE NHX ROCHE DIAGNOSTICS NA 183411

    Patients

    Seq Age Sex Outcome Treatment
    1 045 YR