BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS 5600 INTEGRATED SYSTEM

    MDR report key: 8061722 · Received November 12, 2018

    Report

    Report Number
    1319681-2018-00111
    Event Type
    Malfunction
    Date Received
    November 12, 2018
    Date of Event
    October 15, 2018
    Report Date
    November 12, 2018
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION CONFIRMED THAT RESULTS OBTAINED ON THE VITROS 5600 INTEGRATED SYSTEM FOR FIVE PATIENT SAMPLES PROCESSED FROM ONE SAMPLE TRAY WERE ASSOCIATED WITH THE INCORRECT PATIENT. A DEFINITIVE ASSIGNABLE CAUSE OF THE EVENT COULD NOT BE DETERMINED. THE SCENARIO COULD NOT BE REPLICATED DURING AN INTERNAL INVESTIGATION BY THE SYSTEMS SOFTWARE ENGINEERING R & D TEAM. THERE WAS NO INDICATION OF A SYSTEMIC ISSUE WITH THE VITROS 5600 INTEGRATED SYSTEM HARDWARE OR SOFTWARE. ALL EVIDENCE SUGGESTS THIS WAS AN ISOLATED EVENT. THE VITROS 5600 INTEGRATED SYSTEM DID NOT MALFUNCTION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT RESULTS OBTAINED ON THE VITROS 5600 INTEGRATED SYSTEM FOR FIVE PATIENT SAMPLES PROCESSED FROM ONE SAMPLE TRAY WERE ASSOCIATED WITH THE INCORRECT PATIENT. THE MIS-ASSOCIATION OF PATIENT DEMOGRAPHICS MAY POTENTIALLY LEAD TO INAPPROPRIATE PHYSICIAN ACTION. SAMPLE RESULTS ASSOCIATED WITH THE WRONG PATIENT WERE REPORTED OUT OF THE LABORATORY, HOWEVER THERE WAS NO ALLEGATION OF ACTUAL PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC (ORTHO). COMPLAINT NUMBERS (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    902364 VITROS 5600 INTEGRATED SYSTEM CHEMISTRYANALYZER JJE ORTHO-CLINICAL DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1