BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANTI-CCP

    MDR report key: 5067028 · Received September 10, 2015

    Report

    Report Number
    1823260-2015-04116
    Event Type
    Malfunction
    Date Received
    September 10, 2015
    Date of Event
    August 17, 2015
    Report Date
    October 12, 2015
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    NHX
    PMA / PMN Number
    K081338
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6).

    Additional Manufacturer Narrative · 1

    UPON FURTHER INVESTIGATION, VARIOUS REAGENT AND MAINTENANCE HANDLING ISSUES WERE DISCOVERED AT THE CUSTOMER SITE. THE CUSTOMER IS ALSO USING A CONTROL LOT WHICH IS NOT SPECIFIED FOR ANTI-CCP.

    Additional Manufacturer Narrative · 1

    IT WAS NOTED THAT THE CUSTOMER HAS TESTED THE SAMPLE AT A DIFFERENT SITE ON ANOTHER E411 ANALYZER AND THE RESULT WAS SIMILAR TO THE INITIAL ANTI- CCP RESULT OF 38.82 U/ML. THE ACTUAL RESULT WAS NOT PROVIDED.

    Description of Event or Problem · 1

    THE CUSTOMER COMPLAINED OF ERRONEOUS RESULTS FOR 1 PATIENT SAMPLE TESTED FOR ANTI-CCP. THE ERRONEOUS RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE INITIAL ANTI-CCP RESULT WAS 38.82 U/ML. THIS RESULT WAS REPORTED OUTSIDE OF THE LABORATORY. THE SAMPLE WAS SENT TO 2 EXTERNAL LABORATORIES WHERE THE RESULT FROM A SIEMENS IMMULITE ANALYZER WAS 1.79 U/ML AND THE RESULT FROM AN ABBOTT ARCHITECT ANALYZER WAS 4.80 U/ML. THE SAMPLE WAS ALSO REPEATED ON ANOTHER E411 SYSTEM WHERE THE RESULT WAS 45.41 WITH A DATA FLAG. NO ADVERSE EVENT WAS REPORTED. THE E411 SYSTEM SERIAL NUMBER WAS (B)(4). PREVENTATIVE MAINTENANCE WAS LAST PERFORMED ON 11/13/2014. DURING PERFORMANCE TESTING, THE INSTRUMENT WAS FOUND TO BE OUT OF SPECIFICATION BY THE FIELD SERVICE ENGINEER. CALIBRATION WAS PERFORMED ON 07/16/2015 WHEN THE REAGENT KIT WAS LOADED ONTO THE SYSTEM. THE CUSTOMER USES ANTI-CCP ONCE A WEEK AND RUNS ALL SAMPLES EVERY MONDAY. IT WAS NOTED THAT THE CUSTOMER USES BIORAD QUALITY CONTROLS WHICH DO NOT HAVE VALUES FOR ANTI-CCP. THE CUSTOMER HAS SET A RANGE BASED ON THE VALUES RECEIVED OVER TIME AND IS USING THAT RANGE WHEN RUNNING QUALITY CONTROLS. THE REAGENT KIT WAS RECALIBRATED ON 08/21/2015 WHEN THE CALIBRATION SIGNALS SEEMED LOWER. AFTER RECALIBRATING, THE SIGNAL DROPPED LOWER. THE QUALITY CONTROLS AT THIS TIME WERE WITHIN THE RANGE SET BY THE CUSTOMER. IT WAS NOTED THAT THE CALIBRATION SIGNALS OBTAINED BY THE CUSTOMER WERE TOO LOW FOR BOTH LEVELS AND CALIBRATION IS NOT PERFORMED FREQUENTLY ENOUGH BASED ON MANUFACTURER RECOMMENDATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    600324 ANTI-CCP ANTIBODIES, ANTI-CYCLIC CITRULLINATED PEPTIDE NHX ROCHE DIAGNOSTICS NA 185555

    Patients

    Seq Age Sex Outcome Treatment
    1 049 YR