BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS C501

    MDR report key: 3915333 · Received June 9, 2014

    Report

    Report Number
    3915333
    Event Type
    Malfunction
    Date Received
    June 9, 2014
    Date of Event
    June 2, 2014
    Report Date
    June 9, 2014
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DEVICE TESTING FOR SODIUM AND CHLORIDE FAILED TO REPORT CORRECTLY.MANUFACTURER RESPONSE FOR CHEMISTRY INSTRUMENT, ROCHE COBAS C501 (PER SITE REPORTER).======================THEY ARE TRYING TO FIX IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    334232 COBAS C501 ANALYZER, CHEMISTRY JJE ROCHE DIAGNOSTICS * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *