BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS 350 CHEMISTRY SYSTEM

    MDR report key: 1020249 · Received March 26, 2008

    Report

    Report Number
    1319681-2008-00081
    Event Type
    Malfunction
    Date Received
    March 26, 2008
    Date of Event
    February 27, 2008
    Report Date
    February 27, 2008
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION INTO THIS EVENT DETERMINED THAT THE VITROS 350 WAS OPERATING AS INTENDED. THE PATIENT RESULTS WERE ASSOCIATED WITH THE INCORRECT PATIENT NAME, AS A RESULT OF USER ERROR THAT RESULTED IN A SAMPLE MIX-UP.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT RESULTS FROM ONE PATIENT SAMPLE PROCESSED ON THE VITROS 350 CHEMISTRY SYSTEM WERE ASSOCIATED WITH THE INCORRECT PATIENT NAME. THE VITROS 350 RESULTS WERE REPORTED, HOWEVER, THE DISCREPANCY WAS IDENTIFIED AND A CORRECTED REPORT WAS ISSUED. THERE WAS NO REPORT OF PATIENT HARM AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITROS 350 CHEMISTRY SYSTEM CHEMISTRY ANALYZER JJE ORTHO-CLINICAL DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1