BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS 250 CHEMISTRY SYSTEM

    MDR report key: 16364505 · Received February 13, 2023

    Report

    Report Number
    0001319681-2023-00011
    Event Type
    Malfunction
    Date Received
    February 13, 2023
    Date of Event
    January 17, 2023
    Report Date
    February 13, 2023
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS, INC.
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION DETERMINED THAT A SINGLE PATIENT SAMPLE THAT WAS MIS-ASSOCIATED WITH THE INCORRECT ASSAYS WHEN RUN ON A VITROS 250 CHEMISTRY SYSTEM. THE ASSAYS ASSIGNED TO THE PATIENT WERE NOT THE ASSAYS ORDERED BY THE CUSTOMER. THE ASSIGNABLE CAUSE OF THE EVENT WAS DETERMINED TO BE USER ERROR. THE CUSTOMER REUSED AN SID WITHOUT ENSURING THE SAMPLE PREVIOUSLY PROGRAMMED WITH THE SAME SID WAS PROCESSED TO COMPLETION OR DELETED PRIOR TO REUSE. THE VITROS 250 CHEMISTRY SYSTEM WAS OPERATING AS INTENDED.

    Description of Event or Problem · 0

    A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT A SINGLE PATIENT SAMPLE THAT WAS MIS-ASSOCIATED WITH THE INCORRECT ASSAYS WHEN RUN ON A VITROS 250 CHEMISTRY SYSTEM. THE ASSAYS ASSIGNED TO THE PATIENT WERE NOT THE ASSAYS ORDERED BY THE CUSTOMER. BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED ON PATIENT SAMPLES. IT IS UNKNOWN IF THE RESULTS WERE MIS-ASSOCIATED WITH INCORRECT PATIENT DEMOGRAPHICS. IT IS ALSO UNKNOWN IF ANY MIS-ASSOCIATED RESULTS WERE REPORTED OUT OF THE LABORATORY, HOWEVER, THERE WAS NO REPORTED ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC (ORTHO) COMPLAINT NUMBER (B)(4) AND REPORTABILITY ASSESSMENT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    797973 VITROS 250 CHEMISTRY SYSTEM CHEMISTRY ANALYZER JJE ORTHO-CLINICAL DIAGNOSTICS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown