BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 C501 MODULE

    MDR report key: 1213748 · Received October 22, 2008

    Report

    Report Number
    1823260-2008-07793
    Event Type
    Malfunction
    Date Received
    October 22, 2008
    Date of Event
    October 1, 2008
    Report Date
    October 22, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    DAP
    PMA / PMN Number
    K060373
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    CUSTOMER RECEIVED DISCREPANT D-DIMER RESULTS FOR TWELVE PATIENT SAMPLES, CUSTOMER STATES TOTAL NUMBER IS UNKNOWN SINCE ISSUE BEGAN AT INSTALL (2007). FIVE PATIENT EXAMPLES WERE PROVIDED. PATIENT 1: INITIAL RESULT 0.078 UG/ML, REPEAT <0.10 UG/ML. PATIENT 2, INITIAL RESULT 0.214 UG/ML, REPEAT 0.120 UG/ML. PATIENT 3, INITIAL RESULT 0.757 UG/ML, REPEAT 0.610 UG/ML. PATIENT 4, INITIAL RESULT 8.566 UG/ML, REPEAT 6.659 UG/ML. PATIENT 5, INITIAL RESULT 8.116 UG/ML, REPEAT 6.572 UG/ML. INITIAL RESULTS WERE REPORTED. LAB STATED THE DIFFERENCE BETWEEN ORIGINAL AND RETURN WAS NOT SUFFICIENT ENOUGH TO TAKE ANY CORRECTIVE ACTION. CUSTOMER COULD NOT STATE IF THE PATIENTS WERE ADVERSELY AFFECTED. THE TECHNICAL SERVICE REPRESENTATIVE DETERMINED THE CUSTOMER WAS RUNNING CITRATE SAMPLES ON A HEPARIN APPLICATION CODE AND SHE UPDATED IT TO THE CORRECT CODE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBAS 6000 C501 MODULE CLINICAL CHEMISTRY ANALYZER - CEM DAP ROCHE DIAGNOSTICS C501

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK