BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS 5600 INTEGRATED SYSTEM

    MDR report key: 7351959 · Received March 20, 2018

    Report

    Report Number
    1319681-2018-00027
    Event Type
    Malfunction
    Date Received
    March 20, 2018
    Date of Event
    March 7, 2018
    Report Date
    March 20, 2018
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, 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 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 5600 INTEGRATED 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 5600 USER GUIDE. THE VITROS 5600 INTEGRATED SYSTEM WAS OPERATING AS INTENDED. NO MALFUNCTION OCCURRED.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT AN INCORRECT PATIENT NAME HAD BEEN ASSOCIATED WITH A PATIENT SAMPLE WHEN TESTED ON A VITROS 5600 INTEGRATED 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 (B)(4) / QERTS RECORD ID (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    195474 VITROS 5600 INTEGRATED SYSTEM CHEMISTRY ANALYZER JJE ORTHO-CLINICAL DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1