BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTEGRA 700

    MDR report key: 780953 · Received November 7, 2006

    Report

    Report Number
    1823260-2006-06374
    Event Type
    Malfunction
    Date Received
    November 7, 2006
    Date of Event
    October 12, 2006
    Report Date
    November 7, 2006
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    951595
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    ACCOUNT STATES THEY ARE GETTING VERY POOR PRECISION FOR SEVERAL ASSAYS. THE INCORRECT RESULTS HAVE NOT BEEN USED TO GUIDE PATIENT THERAPY. THE FIELD SERVICE REP FOUND THE LDD CABLE WAS BROKEN AND REPAIRED THE INSTRUMENT BY REPLACING THE CABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTEGRA 700 CLINICAL CHEMISTRY ANALYZER JJE JJE ROCHE DIAGNOSTICS * *

    Patients

    Seq Age Sex Outcome Treatment
    1 NA