BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 C501MODULE

    MDR report key: 1421843 · Received April 27, 2009

    Report

    Report Number
    1823260-2009-02996
    Event Type
    Malfunction
    Date Received
    April 27, 2009
    Date of Event
    January 5, 2009
    Report Date
    April 27, 2009
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    DAP
    PMA / PMN Number
    K060373
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    USER RECEIVED DISCREPANT D-DIMER RESULTS FOR 3 PATIENT SAMPLES WHICH WERE TESTED ON TWO DIFFERENT METHODS. THE SAMPLES WERE RUN ON THE TRIAGE D-DIMER BY BIOSITE IN THE EMERGENCY DEPARTMENT AT THE SITE AND BY THE ROCHE D-DIMER RUN ON THE COBAS C501 IN THE CORE LABORATORY. SAMPLE 1 TRIAGE RESULT WAS LESS THAN 100-NEGATIVE, AND THE ROCHE D-DIMER RESULT WAS 3798 NG PER ML. SAMPLE 2 FROM 3-9-09, TRIAGE RESULT WAS LESS THAN 100-NEGATIVE AND THE ROCHE D-DIMER RESULT WAS 908 NG PER ML. SAMPLE 3 FROM 2009, TRIAGE RESULT WAS 101-NEGATIVE AND THE ROCHE D-DIMER RESULT WAS 4384 NG PER ML. THE ERRONEOUS RESULTS WERE REPORTED. THE USER STATED THE PATIENTS WERE NOT TREATED BASED ON THE RESULTS. THE USER STATED HE DID NOT FEEL THIS WAS AN INSTRUMENT ISSUE, BUT POSSIBLY AN INTERFERANT. HE DID NOT WANT A FIELD SERVICE REPRESENTATIVE VISIT. IF ADDITIONAL INFORMATION IS RECEIVED, APPROPRIATE NOTIFICATION WILL BE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBAS 6000 C501MODULE CLINICAL CHEMISTRY ANALYZER - CEM DAP ROCHE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK