BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS 350 CHEMISTRY SYSTEM

    MDR report key: 1943932 · Received January 3, 2011

    Report

    Report Number
    1319681-2010-00294
    Event Type
    Malfunction
    Date Received
    January 3, 2011
    Date of Event
    December 6, 2010
    Report Date
    January 3, 2011
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER RE-USES PATIENT SAMPLE ID NUMBERS. THE CUSTOMER RE-USED A SAMPLE ID THAT HAD PENDING TESTS STORED IN THE ANALYZER. THE DEVICE LABELING, LOCATED IN THE VITROS 250/350 CHEMISTRY SYSTEM OPERATOR'S MANUAL DESCRIBES HOW TO MANAGE SAMPLE ID NUMBERS THAT WERE PREVIOUSLY USED AND NOT PROCESSED TO COMPLETION OR DELETED. IF A SAMPLE IS NOT PROCESSED TO COMPLETION, THE SAMPLE PROGRAMMING AND ASSOCIATED DEMOGRAPHICS DATA ARE RETAINED BY THE ANALYZER IN A 'PENDING' STATE, AS PER THE DESIGN OF THE SOFTWARE. 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 ROOT CAUSE OF THIS EVENT IS USER ERROR.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT RESULTS FOR A SINGLE PATIENT SAMPLE OBTAINED FROM A VITROS 350 CHEMISTRY SYSTEM WERE ASSOCIATED WITH THE INCORRECT PATIENT. THE MIS-ASSOCIATED RESULTS WERE NOT REPORTED TO THE CLINICIAN. THERE WAS NO ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS, INC. (B)(4)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITROS 350 CHEMISTRY SYSTEM CHEMISTRY ANALYZER JJE ORTHO-CLINICAL DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1