BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANALYTICAL E MODULE

    MDR report key: 3573140 · Received January 14, 2014

    Report

    Report Number
    1823260-2014-00288
    Event Type
    Malfunction
    Date Received
    January 14, 2014
    Date of Event
    December 24, 2013
    Report Date
    March 4, 2014
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    NIG
    PMA / PMN Number
    K961481
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. THE PATIENT'S SAMPLE WAS TESTED USING THE CENTAUR METHOD WITH A 1:100 DILUTION AND THE RESULT WAS 18500 U/ML, WHICH WAS IN AGREEMENT WITH THE ELECSYS RESULT AT A 1:100 DILUTION. PER THE PACKAGE INSERT, THE CA 19-9 ANTIGEN TENDS TO AGGREGATE WHICH CAN LEAD TO NON-LINEAR DILUTION BEHAVIOR. THE ELECSYS RESULT WAS LIKELY CORRECT.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGED THEY RECEIVED A QUESTIONABLE CARBOHYDRATE ANTIGEN 19-9 (CA 19-9) RESULTS FOR ONE PATIENT ON THEIR E-MODULE. THE CUSTOMER WOULD NOT PROVIDE THE SPECIFIC DATE OF THIS EVENT. THE PATIENT'S INITIAL RESULT WAS >1000 U/ML. THE SAMPLE WAS DILUTED 1:5 AND THE RESULT WAS 3268.5 U/ML. THE SAMPLE WAS DILUTED 1:10 AND THE RESULT WAS 5192 U/ML. THE SAMPLE WAS DILUTED 1:20 AND THE RESULT WAS 8042 U/ML. THE SAMPLE WAS DILUTED 1:100 AND THE RESULT WAS 15990 U/ML. THE SAMPLE WAS DILUTED 1:400 AND THE RESULT WAS 21392 U/ML. THE CUSTOMER WOULD NOT PROVIDE INFORMATION ON WHETHER ANY OF THE RESULTS WERE REPORTED OUTSIDE THE LABORATORY. THERE WERE NO DEATHS, INJURIES, ILLNESSES, OR DETERIORATIONS IN HEALTH ASSOCIATED WITH THE ERRONEOUS RESULTS. THE CUSTOMER WOULD NOT PROVIDE INFORMATION ON WHETHER THE PATIENT WAS HARMED BY ANY ACTIONS TAKEN. THE CA 19-9 REAGENT LOT NUMBER WAS 172934 AND THE EXPIRATION DATE WAS 12/30/2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    37105 ANALYTICAL E MODULE IMMUNOCHEMISTRY ANALYZER NIG ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1