BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS INTEGRA 400 PLUS

    MDR report key: 1041306 · Received May 9, 2008

    Report

    Report Number
    1823260-2008-03901
    Event Type
    Malfunction
    Date Received
    May 9, 2008
    Date of Event
    April 14, 2008
    Report Date
    May 9, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    DAP
    PMA / PMN Number
    K951595
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    ONE PT WITH DISCREPANT D-DIMER RESULTS. INITIAL RESULT GAVE <0.000 UG/ML; REPEATED GAVE SAME RESULTS. SAMPLE WAS REPEATED AGAIN TWICE GIVING 1.52 AND 1.57 UG/ML. A SECOND SAMPLE WAS OBTAINED FROM A SUBSEQUENT VISIT WHICH RESULTED AT 0.9 UG/ML. NO INFO PROVIDED TO DETERMINE IF RESULTS WERE USED TO GUIDE THERAPY. NO FURTHER INVESTIGATION POSSIBLE, AS SAMPLE IS NO LONGER AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBAS INTEGRA 400 PLUS CLINICAL CHEMISTRY ANALYZER - JJE DAP ROCHE DIAGNOSTICS I400+

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK