BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS 5600 INTEGRATED SYSTEM

    MDR report key: 2944487 · Received February 5, 2013

    Report

    Report Number
    1319681-2013-00041
    Event Type
    Malfunction
    Date Received
    February 5, 2013
    Date of Event
    December 27, 2012
    Report Date
    February 5, 2013
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT RESULTS FOR A SINGLE PATIENT SAMPLE WAS ASSOCIATED WITH AN UNINTENDED PATIENT. LIMITED INFORMATION WAS PROVIDED TO ASSIST IN THE INVESTIGATION. THERE WAS NO EVIDENCE TO SUGGEST AN INSTRUMENT MALFUNCTION. FURTHERMORE, USER ERROR WITH REGARDS TO SAMPLE PROGRAMMING CANNOT BE RULED OUT AS A CONTRIBUTING FACTOR. THE ROOT CAUSE OF THE EVENT IS UNKNOWN.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT RESULTS FROM A SINGLE PATIENT SAMPLE OBTAINED USING A VITROS 5600 SYSTEM WAS ASSOCIATED WITH THE INCORRECT PATIENT NAME. MIS-ASSOCIATED PATIENT RESULTS MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION. THERE WAS NO REPORT THAT ERRONEOUS RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THERE WAS NO REPORT OF PATIENT HARM AS A RESULT OF THIS EVENT. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    49348 VITROS 5600 INTEGRATED SYSTEM CHEMISTRY ANALYZER JJE ORTHO-CLINICAL DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1