BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 E601 MODULE

    MDR report key: 1371834 · Received February 13, 2009

    Report

    Report Number
    1823260-2009-01187
    Event Type
    Malfunction
    Date Received
    February 13, 2009
    Date of Event
    December 29, 2008
    Report Date
    February 13, 2009
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LOJ
    PMA / PMN Number
    K060373
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    USER RECEIVED DISCREPANT AFP RESULTS FOR THREE SAMPLES FROM ONE PT WHEN COMPARED TO ANOTHER ANALYZER. IN 2008, THE RESULT FROM THIS ANALYZER WAS 2.74 AND RESULT FROM OTHER ANALYZER WAS 21.01 UI PER ML. IN 2009, THE RESULT FROM THIS ANALYZER WAS 3.48 AND RESULT FROM OTHER ANALYZER WAS 24.36 UI PER ML. ATABOUT 21 DAYS LATER, THE RESULT FROM THIS ANALYZER WAS 4.7 AND RESULT FROM OTHER ANALYZER WAS 30.39 UI PER ML. NO INFO WAS PROVIDED TO DETERMINE WHICH RESULT WAS REPORTED OR IF PT WAS ADVERSELY AFFECTED. IF ADDITIONAL INFO IS RECEIVED, APPROPRIATE NOTIFICATION WILL BE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBAS 6000 E601 MODULE IMMUNOCHEMISTRY ANALYZER - CEM LOJ ROCHE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR SOLUMEDROL| ZOPHREN| ETOPOSIDE| CISPLATINE| BLEOMYCINE| EMEND