BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 8000 E602 MODULE

    MDR report key: 3201161 · Received July 2, 2013

    Report

    Report Number
    1823260-2013-03981
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Date of Event
    June 19, 2013
    Report Date
    July 17, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K100853
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DUE TO THE CUSTOMER NOT PROVIDING THE REQUESTED INFORMATION THE INVESTIGATION COULD NOT DETERMINE A ROOT CAUSE.

    Additional Manufacturer Narrative · 1

    THE EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGED A QUESTIONABLE RESULT ON ONE PATIENT SAMPLE WHEN TESTED FOR CARCINOEMBRYONIC ANTIGEN (CEA). THE INITIAL CEA RESULT WAS 43 NG/ML. THIS RESULT WAS REPORTED TO THE PHYSICIAN. A REQUEST FOR RE-MEASUREMENT WAS MADE BECAUSE THE RESULT DID NOT MATCH THE PATIENT'S CLINICAL CONDITION. THE TEST WAS REPEATED WITH A RESULT OF 1.5 NG/ML. NO ADVERSE EVENT OCCURRED. THE CUSTOMER WAS ASKED FOR, BUT DID NOT PROVIDE, THE LOT NUMBER AND EXPIRATION DATE OF THE REAGENT INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303256 COBAS 8000 E602 MODULE IMMUNOCHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1