BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS ECIQ IMMUNODIAGNOSTIC SYSTEM

    MDR report key: 1695224 · Received May 20, 2010

    Report

    Report Number
    1319681-2010-00099
    Event Type
    Malfunction
    Date Received
    May 20, 2010
    Date of Event
    April 21, 2010
    Report Date
    May 20, 2010
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    KHO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER RE-USES SAMPLE ID NUMBERS. THE CUSTOMER RE-USED SAMPLE ID'S THAT HAD PENDING RESULTS STORED IN THE ANALYZER. THE DEVICE LABELING, LOCATED IN THE VITROS ECIQ OPERATOR'S GUIDE 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 FROM SEVERAL PATIENT SAMPLES OBTAINED FROM TWO VITROS ECIQ IMMUNODIAGNOSTIC SYSTEMS WERE ASSOCIATED WITH THE INCORRECT PATIENT NAMES. THE INCORRECT PATIENT NAMES WERE IDENTIFIED BY THE CUSTOMER, SO NO ERRONEOUS RESULTS WERE REPORTED FROM THE LABORATORY. THERE WAS NO REPORT OF PATIENT HARM AS A RESULT OF THIS EVENT. ( B)(4).THIS REPORT IS ONE OF TWO MDRS FOR THIS EVENT. TWO 3500A FORMS ARE BEING SUBMITTED FOR THIS EVENT AS TWO DEVICES WERE INVOLVED.THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC. COMPLAINT NUMBER 318589477 & 31589483 /IVD 170496.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITROS ECIQ IMMUNODIAGNOSTIC SYSTEM IMMUNODIAGNOSTIC ANALYZER KHO ORTHO-CLINICAL DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1