BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1823260-2015-04202

    MDR report key: 5093547 · Received September 22, 2015

    Report

    Report Number
    1823260-2015-04202
    Event Type
    Malfunction
    Date Received
    September 22, 2015
    Date of Event
    September 8, 2015
    Report Date
    September 22, 2015
    PMA / PMN Number
    K060373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER DID NOT CHECK QUALITY CONTROL (QC) RESULTS PRIOR TO PROCESSING PATIENT RESULTS TESTED FOR CARCINOEMBRYONIC ANTIGEN (CEA) AND REPORTED THEM OUTSIDE OF THE LABORATORY. THE CUSTOMER WAS ADVISED TO RE- CALIBRATE, RUN QC AND REPEAT THE PATIENT SAMPLES. AFTER PERFORMING REPEAT TESTING, ERRONEOUS RESULTS FOR 7 PATIENT SAMPLES WERE IDENTIFIED. THE ERRONEOUS RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. PATIENT 1 INITIAL CEA RESULT WAS 9.66 NG/ML. THIS RESULT WAS REPORTED OUTSIDE OF THE LABORATORY. THE REPEAT RESULT WAS 4.02 NG/ML. PATIENT 2 INITIAL CEA RESULT WAS 4.86 NG/ML. THIS RESULT WAS REPORTED OUTSIDE OF THE LABORATORY. THE REPEAT RESULT WAS 1.88 NG/ML. PATIENT 3 INITIAL CEA RESULT WAS 5.78 NG/ML. THIS RESULT WAS REPORTED OUTSIDE OF THE LABORATORY. THE REPEAT RESULT WAS 2.18 NG/ML. PATIENT 4 INITIAL CEA RESULT WAS 9.88 NG/ML. THIS RESULT WAS REPORTED OUTSIDE OF THE LABORATORY. THE REPEAT RESULT WAS 4.12 NG/ML. PATIENT 5 INITIAL CEA RESULT WAS 11.01 NG/ML. THIS RESULT WAS REPORTED OUTSIDE OF THE LABORATORY. THE REPEAT RESULT WAS 4.58 NG/ML. PATIENT 6 INITIAL CEA RESULT WAS 5.85 NG/ML. THIS RESULT WAS REPORTED OUTSIDE OF THE LABORATORY. THE REPEAT RESULT WAS 2.26 NG/ML. PATIENT 7 INITIAL CEA RESULT WAS 5.06 NG/ML. THIS RESULT WAS REPORTED OUTSIDE OF THE LABORATORY. THE REPEAT RESULT WAS 1.97 NG/ML. NO ADVERSE EVENT OCCURRED. THE CEA REAGENT LOT NUMBER WAS 180801 WITH AN EXPIRATION DATE OF 02/2016. BASED ON THE AVAILABLE DATA, THE ERRONEOUS RESULTS WERE CAUSED BY THE LOW CALIBRATION SIGNALS. QC RESULTS INDICATED THIS; HOWEVER, THE CUSTOMER DID NOT CHECK THE QC RESULTS PRIOR TO PROCESSING THE PATIENT SAMPLES.

    Patients

    Seq Age Sex Outcome Treatment
    1