BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS 3600 IMMUNODIAGNOSTIC SYSTEM

    MDR report key: 7409822 · Received April 9, 2018

    Report

    Report Number
    1319681-2018-00031
    Event Type
    Malfunction
    Date Received
    April 9, 2018
    Date of Event
    March 15, 2018
    Report Date
    April 9, 2018
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    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 SYSTEM. ASSAY RESULTS WERE GENERATED FOR A SAMPLE WHEN THE ASSAYS WERE NOT ORDERED AND WERE ASSOCIATED WITH THE INCORRECT PATIENT NAME. THE SAMPLE HAD BEEN PROCESSED ON A VITROS 3600 IMMUNODIAGNOSTIC SYSTEM. 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 3600 USER GUIDE. THE VITROS 3600 IMMUNODIAGNOSTIC SYSTEM WAS OPERATING AS INTENDED. NO MALFUNCTION OCCURRED.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT RESULTS OBTAINED ON THE VITROS 3600 IMMUNODIAGNOSTIC SYSTEM FOR A PATIENT SAMPLE WERE MIS-ASSOCIATED WITH THE INCORRECT PATIENT SID NUMBER. 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. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    248770 VITROS 3600 IMMUNODIAGNOSTIC SYSTEM CHEMISTRY ANALYZER JJE ORTHO-CLINICAL DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1