BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1823260-2015-04467

    MDR report key: 5210603 · Received November 9, 2015

    Report

    Report Number
    1823260-2015-04467
    Event Type
    Malfunction
    Date Received
    November 9, 2015
    Date of Event
    October 19, 2015
    Report Date
    November 9, 2015
    PMA / PMN Number
    K961481
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THEY RECEIVED QUESTIONABLE RESULTS FOR A TOTAL OF TWO PATIENT SAMPLES TESTED FOR CARCINOEMBRYONIC ANTIGEN (CEA) AND CARBOHYDRATE ANTIGEN 19-9 (CA 19-9). OF THE TWO SAMPLES, ONE HAD AN ERRONEOUS CEA RESULT THAT WAS REPORTED OUTSIDE OF THE LABORATORY. THE SAMPLE INITIALLY RESULTED AS 8.10 NG/ML ON (B)(6) 2015 AND THIS VALUE WAS REPORTED OUTSIDE OF THE LABORATORY. THE SAMPLE WAS KEPT FROZEN. THE SAMPLE WAS LATER REPEATED ON (B)(6) 2015, RESULTING AS 4.87 NG/ML. THE 4.87 NG/ML VALUE WAS REPORTED OUTSIDE OF THE LABORATORY AND THE PHYSICIAN ASKED THE LABORATORY TO CONFIRM THE RESULT. THE SAMPLE WAS REPEATED ON (B)(6) 2015, RESULTING AS 8.22 NG/ML. BOTH THE 8.10 NG/ML AND 8.22 NG/ML VALUES WERE CONSIDERED TO BE CORRECT. THE PATIENT WAS NOT ADVERSELY AFFECTED. CEA REAGENT LOT NUMBER 180517 WAS USED FOR THE FIRST AND SECOND MEASUREMENTS OF THE SAMPLE. THE EXPIRATION DATE FOR THIS REAGENT WAS ASKED FOR, BUT NOT PROVIDED. CEA REAGENT LOT NUMBER 185797 WAS USED FOR THE THIRD MEASUREMENT OF THE SAMPLE. THE EXPIRATION DATE FOR THIS REAGENT WAS ASKED FOR, BUT NOT PROVIDED. THE FIELD SERVICE ENGINEER NOTICED THE PRESENCE OF FIBRIN IN THE PATIENT SAMPLE. A SPECIFIC ROOT CAUSE COULD NOT BE DETERMINED BASED ON THE PROVIDED INFORMATION. THE PROVIDED CALIBRATION AND CONTROL DATA DO NOT REVEAL ANY GENERAL ISSUE WITH THE PRODUCTS USED AS RESULTS ARE WITHIN SPECIFICATIONS. THE FIELD SERVICE ENGINEER FOUND FIBRIN IN THE SAMPLE. THE MOST LIKELY ROOT CAUSE OF THE INCORRECT RESULT IS FIBRIN IN THE SAMPLE.

    Patients

    Seq Age Sex Outcome Treatment
    1 050 YR LEVOTIROXINA