BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS 3600 IMMUNODIAGNOSTIC SYSTEM

    MDR report key: 8925852 · Received August 23, 2019

    Report

    Report Number
    1319681-2019-00072
    Event Type
    Malfunction
    Date Received
    August 23, 2019
    Date of Event
    July 29, 2019
    Report Date
    August 23, 2019
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT A DISCORDANT, (B)(6) RESULT WAS OBTAINED FROM A SINGLE PATIENT SAMPLE TESTED USING (B)(6) ON A VITROS 3600 IMMUNODIAGNOSTIC SYSTEM. THE ROOT CAUSE OF THE EVENT WAS DETERMINED TO BE USER ERROR DUE TO INCORRECT CLEANING MAINTENANCE AND SUBSEQUENT CONTAMINATION OF THE MICROWELL INCUBATOR. THE VITROS 3600 IMMUNODIAGNOSTIC SYSTEM IN USE DURING THE EVENT WAS OPERATING AS INTENDED. THE VITROS USER GUIDE INSTRUCTS CUSTOMERS NOT TO USE CHLORINE-BASED CLEANING SOLUTIONS AS THEY HAVE THE POTENTIAL TO CAUSE ERRONEOUS RESULTS ON THE VITROS SYSTEM. THE ORTHO FE DEMONSTRATED TO THE CUSTOMER THE CORRECT PROCEDURE FOR CLEANING OF THE MICROWELL INCUBATOR.

    Description of Event or Problem · 1

    A CUSTOMER OBTAINED A DISCORDANT, (B)(6) FROM A SINGLE PATIENT SAMPLE TESTED USING (B)(6) ON A VITROS 3600 IMMUNODIAGNOSTIC SYSTEM. PATIENT 1, SAMPLE 1, (B)(6) RESULT OF (B)(6) VERSUS THE EXPECTED (B)(6) RESULT OF (B)(6). BIASED RESULTS OF THE DIRECTION AND MAGNITUDE OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF UNDETECTED. THE DISCORDANT, (B)(6) RESULT WAS NOT REPORTED FROM THE LABORATORY AND ORTHO HAS NOT BEEN MADE AWARE OF ANY ALLEGATION OF ACTUAL PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC (ORTHO). COMPLAINT NUMBERS (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    721811 VITROS 3600 IMMUNODIAGNOSTIC SYSTEM CHEMISTRY ANALYZER JJE ORTHO-CLINICAL DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1