BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS 350 CHEMISTRY SYSTEM

    MDR report key: 7058868 · Received November 27, 2017

    Report

    Report Number
    1319681-2017-00114
    Event Type
    Malfunction
    Date Received
    November 27, 2017
    Date of Event
    November 2, 2017
    Report Date
    November 27, 2017
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT A DISCORDANT PATIENT TEST REPORT WAS OBTAINED WHEN COMPARED WITH THE INFORMATION DISPLAYED IN THE CUSTOMER¿S LIS. THE SAMPLE HAD BEEN PROCESSED ON A VITROS 350 CHEMISTRY SYSTEM S/N (B)(4). THE ASSIGNABLE CAUSE OF THE EVENT WAS DETERMINED TO BE USER ERROR AS THE CUSTOMER REUSED A SAMPLE IDENTIFICATION NUMBER (SID) WITHOUT ENSURING THAT THE PREVIOUS SAMPLE PROGRAM FOR THE SID NUMBER WAS PROCESSED TO COMPLETION OR DELETED PRIOR TO USE AS INSTRUCTED IN THE VITROS 350 OPERATOR'S GUIDE. THE VITROS 350 CHEMISTRY SYSTEM WAS OPERATING AS INTENDED. NO MALFUNCTION OCCURRED.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT A DISCORDANT PATIENT TEST REPORT WAS OBTAINED WHEN COMPARED WITH THE INFORMATION DISPLAYED IN THE CUSTOMER¿S LABORATORY INFORMATION SYSTEM (LIS). THE SAMPLE HAD BEEN PROCESSED ON A VITROS 350 CHEMISTRY SYSTEM. RESULTS THAT HAVE BEEN ASSOCIATED WITH THE WRONG PATIENT MAY LEAD TO INAPPROPRIATE INTERVENTION WITH THE POTENTIAL FOR SERIOUS INJURY TO THE PATIENT. NO MIS-ASSOCIATED RESULTS WERE REPORTED FROM THE LABORATORY. THERE IS NO ALLEGATION OF PATIENT HARM RELATED TO THIS EVENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS (ORTHO) INC. COMPLAINT NUMBER 1955438 / QERTS RECORD ID 419628.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    838794 VITROS 350 CHEMISTRY SYSTEM CHEMISTRY ANALYZER JJE ORTHO-CLINICAL DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1