BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS 4600 CHEMISTRY SYSTEM

    MDR report key: 16097693 · Received January 4, 2023

    Report

    Report Number
    0001319681-2023-00001
    Event Type
    Malfunction
    Date Received
    January 4, 2023
    Date of Event
    December 9, 2022
    Report Date
    January 4, 2023
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS, INC.
    Product Code
    JJE
    UDI-DI
    10758750012343
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ON (B)(6) 2022, A CUSTOMER REPORTED THAT WHEN THEIR VITROS 4600 CHEMISTRY SYSTEM WAS RUNNING A SAMPLE IN POSITION 1, IT WOULD THEN GO TO POSITION 5 FOR REFLEX DILUTION. IN THE OBSERVED CASE, NO TUBE WAS IN POSITION 5. THE INVESTIGATION DETERMINED THAT THE ASSIGNABLE CAUSE OF THE EVENT WAS USER ERROR. THE INVESTIGATION ESTABLISHED THAT THE SAHA_REFLEX_POS SETTING HAD BEEN CHANGED ON 01 DECEMBER 2022 BY AN UNKNOWN PERSON. THE SAHA_REFLEX_POS SETTING WAS RESET AND OPTIMIZED BY AN ORTHO FIELD ENGINEER (FE) AND ONCE CORRECTED, ACCEPTABLE INSTRUMENT PERFORMANCE WAS DEMONSTRATED TO THE CUSTOMER. THE CUSTOMER WAS SATISFIED WITH THE ORTHO FE ACTIONS PERFORMED AND WILL MONITOR THE INSTRUMENT PERFORMANCE OVER THE COMING DAYS AND INFORM ORTHO OF ANY FURTHER INCIDENTS IF OBSERVED.

    Description of Event or Problem · 0

    ON (B)(6) 2022, A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT THAT THEIR VITROS 4600 CHEMISTRY SYSTEM WAS RUNNING A SAMPLE IN POSITION 1, IT WOULD THEN GO TO POSITION 5 FOR REFLEX DILUTION. IN THE OBSERVED CASE, NO TUBE WAS IN POSITION 5. BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED. THE CUSTOMER IDENTIFIED THE DISCREPANCY, AND NO ERRONEOUS RESULTS WERE KNOWINGLY REPORTED FROM THE LABORATORY. THE CUSTOMER AND ORTHO HAVE NOT BEEN MADE AWARE OF ANY ALLEGATIONS OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC (ORTHO) COMPLAINT NUMBER: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1118834 VITROS 4600 CHEMISTRY SYSTEM CHEMISTRY ANALYZER JJE ORTHO-CLINICAL DIAGNOSTICS, INC. 6802445 10758750012343

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown