BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITROS 5600 INTEGRATED SYSTEM

    MDR report key: 1503595 · Received October 9, 2009

    Report

    Report Number
    1319681-2009-00316
    Event Type
    Injury
    Date Received
    October 9, 2009
    Date of Event
    September 15, 2009
    Report Date
    September 15, 2009
    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

    INVESTIGATION INTO THIS EVENT DETERMINED THAT THE VITROS 5600 WAS OPERATING AS INTENDED. THE CUSTOMER RE-USES SAMPLE ID NUMBERS. THE CUSTOMER REUSED A SAMPLE ID THAT HAD PENDING RESULTS STORED IN THE ANALYZER. IF A SAMPLE IS NOT PROCESSED TO COMPLETION, THE SAMPLE PROGRAMMING AND ASSOCIATED DEMOGRAPHICS DATA ARE RETAINED BY THE ANALYZER IN A "PENDING" STATE. RE-USING THE SAMPLE ID ON A DIFFERENT SAMPLE WITHOUT COMPLETION OF THE ORIGINAL REQUEST OR THE DELETION OF THE PENDING TESTING, WILL CAUSE THE ORIGINAL INFORMATION TO BE CARRIED FORWARD. THE CUSTOMER WAS AWARE OF THE SAMPLE PROGRAM RETENTION FEATURE OF THE VITROS 5600 SOFTWARE WHICH ENABLES THE OPERATOR TO RE-PRESENT A SAMPLE THAT WAS NOT PROCESSED TO COMPLETION, WITHOUT THE NEED TO RE-PROGRAM THE VITROS 5600 INTEGRATED SYSTEM. THE CUSTOMER HAD THE SOFTWARE AUTO DELETE FEATURE SET TO 30 DAYS. THE CUSTOMER HAD RE-CONFIGURED THE AUTO DELETE FEATURE TO 7 DAYS FOLLOWING THIS EVENT. THE ROOT CAUSE OF THIS EVENT IS USER ERROR.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT RESULTS FOR A SINGLE PATIENT SAMPLE PROCESSED ON A VITROS 5600 INTEGRATED SYSTEM WERE ASSOCIATED WITH THE INCORRECT PATIENT DEMOGRAPHICS. THE ERRONEOUS RESULTS WERE REPORTED OUT OF THE LABORATORY AND QUESTIONED BY THE PHYSICIAN. THERE WERE NO ALLEGATIONS OF HARM AS A RESULT OF THIS EVENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1