BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS ECIQ IMMUNODIAGNOSTIC SYSTEM

    MDR report key: 1051533 · Received May 14, 2008

    Report

    Report Number
    1319681-2008-00140
    Event Type
    Malfunction
    Date Received
    May 14, 2008
    Date of Event
    April 18, 2008
    Report Date
    April 18, 2008
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION INTO THIS EVENT CONCLUDES THAT RESULTS OBTAINED FROM THE VITROS ECIQ WERE ASSOCIATED WITH AN INCORRECT PATIENT NAME. A USER HAD PROGRAMMED THE CORRECT SAMPLE ID FOR THE TUBE IN USE AND THEN ANOTHER USER REPLACED THE SAMPLE TUBE WITH A DIFFERENT PATIENT SAMPLE TUBE AND DID NOT UPDATE SAMPLE PROGRAMMING WITH THE UPDATED SAMPLE ID. INSTRUMENT ERROR CODES WERE GENERATED TO CALL ATTENTION TO THIS SAMPLE IDENTIFICATION BARCODE MISMATCH. REPEAT ANALYSIS OF THE CORRECTLY IDENTIFIED SAMPLES HAS RESOLVED THE EVENT AND EXPECTED RESULTS WERE THEN GENERATED AND REPORTED. THE ANALYZER IS OPERATING AS INTENDED AND NO MALFUNCTION OF THE EQUIPMENT WAS IDENTIFIED. THE ROOT CAUSE FOR THIS EVENT IS USER ERROR.

    Description of Event or Problem · 1

    A CUSTOMER OBSERVED RESULTS FROM ONE PATIENT ASSOCIATED WITH THE SAMPLE ID FROM ANOTHER PATIENT. UNDER THESE CONDITIONS, IF THE RESULTS HAD BEEN REPORTED IT COULD LEAD TO INAPPROPRIATE PHYSICIAN ACTION. THE PATIENT RESULTS ASSOCIATED WITH THIS EVENT WERE NOT REPORTED AND THERE WAS NO REPORT OF PATIENT HARM. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS, INC.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1