BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS 5, 1 FS CHEMISTRY SYSTEM

    MDR report key: 1010171 · Received March 7, 2008

    Report

    Report Number
    1319681-2008-00063
    Event Type
    Malfunction
    Date Received
    March 7, 2008
    Date of Event
    February 8, 2008
    Report Date
    February 8, 2008
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION INTO THIS EVENT SHOWED THAT THE USER EDITED THE SAMPLE PROGRAMMING WHICH RESULTED IN MISMATCHED SAMPLE ID AND PATIENT DEMOGRAPHICS. THE CURRENT DEVICE LABELING INDICATES THAT USE OF THE SAVE/NEXT TARGET WILL SAVE ALL CHANGES, INCLUDING THE SAMPLE ID. USER ERROR WAS THE ROOT CAUSE OF THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER OBSERVED PATIENT SAMPLE RESULTS ASSOCIATED WITH THE WRONG PATIENT DEMOGRAPHICS ON THE 5, 1 FS ANALYZER. NO ERRONEOUS RESULTS WERE REPORTED. MIS-ASSOCIATION OF PATIENT DEMOGRAPHICS AND RESULTS MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION. THERE WAS NO REPORT OF PATIENT HARM AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITROS 5, 1 FS CHEMISTRY SYSTEM CLINICAL CHEMISTRY ANALYZER JJE ORTHO-CLINICAL DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1