BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANALYTICAL E MODULE

    MDR report key: 3883723 · Received June 19, 2014

    Report

    Report Number
    1823260-2014-04464
    Event Type
    Malfunction
    Date Received
    June 19, 2014
    Date of Event
    May 27, 2014
    Report Date
    July 23, 2014
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K961481
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A ROOT CAUSE COULD NOT BE DETERMINED WITH THE INFORMATION PROVIDED. ADDITIONAL DATA WERE REQUESTED BUT NOT PROVIDED. THE CALIBRATION AND QUALITY CONTROL RESULTS WERE WITHIN RANGE AND THERE WAS NO INDICATION OF A GENERAL REAGENT OR SYSTEM ISSUE. IT WAS NOTED THE CUSTOMER WAS NOT USING THE RECOMMENDED RACK ADAPTORS. THE PERFORMANCE TESTING DATA WERE WITHIN SPECIFICATIONS. THE MEASURING CELLS WERE EXCHANGED.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGED THEY RECEIVED QUESTIONABLE CARCINOEMBRYONIC ANTIGEN (CEA), CMV IGG, TOXO IGG, AND CA 15-3 RESULTS ON THEIR E-MODULE. THE CUSTOMER PROVIDED DATA FOR FIVE PATIENTS, OF WHICH THERE WERE TWO PATIENTS WITH DISCREPANT CEA RESULTS. THE CUSTOMER STATED THE FIRST PATIENT'S SAMPLE WAS CHECKED FOR CLOTS OR FIBRIN STRANDS, BUT NOT THE SECOND PATIENT'S SAMPLE. THE UNITS OF MEASURE WERE REQUESTED BUT NOT PROVIDED. THE FIRST PATIENT SAMPLE WAS TESTED IN A SAMPLE CUP AND THE INITIAL CEA RESULT WAS 81.06 ACCOMPANIED BY A DATA FLAG. THE FIRST REPEAT RESULT WAS 609.0 ACCOMPANIED BY A DATA FLAG. THE SECOND REPEAT RESULT WAS 604.4. THE SECOND PATIENT'S INITIAL CEA RESULT WAS 9.26. THE REPEAT RESULT WAS 3.30. INFORMATION ON WHETHER THE DISCREPANT RESULTS WERE REPORTED OUTSIDE THE LABORATORY WAS REQUESTED BUT NOT PROVIDED. INFORMATION ON WHETHER THE PATIENTS WERE ADVERSELY AFFECTED WAS REQUESTED BUT NOT PROVIDED. THE CEA REAGENT LOT NUMBER AND EXPIRATION DATE WERE REQUESTED BUT NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    360070 ANALYTICAL E MODULE IMMUNOCHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 078 YR