BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS 5600 INTEGRATED SYSTEM

    MDR report key: 17914337 · Received October 11, 2023

    Report

    Report Number
    0001319681-2023-00057
    Event Type
    Malfunction
    Date Received
    October 11, 2023
    Date of Event
    September 18, 2023
    Report Date
    October 11, 2023
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS, INC.
    Product Code
    JJE
    UDI-DI
    10758750002740
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION DETERMINED THAT HIGHER THAN EXPECTED VITROS CRBM RESULTS WERE OBTAINED FROM A VITROS THERAPEUTIC DRUG MONITORING (TDM) PERFORMANCE VERIFIER (PV) WHEN PROCESSING A DIAGNOSTIC PRECISION TEST USING VITROS CHEMISTRY PRODUCTS CRBM SLIDES LOT 3912-0119-9653 ON A VITROS 5600 INTEGRATED SYSTEM. THE ASSIGNABLE CAUSE OF THE EVENT IS AN INSTRUMENT RELATED ISSUE. PRIOR TO THE EVENT MULTIPLE CONDITION CODES REGARDING THE HUMIDITY OF THE ANALYZER POSTED ON THE VITROS 5600 SYSTEM. AN ORTHO FIELD ENGINEER REPLACED THE HUMIDITY BOX ON THE ANALYZER. FOLLOWING SERVICE ACTIONS, THERE HAS BEEN NO REPORTED RECURRENCE OF HIGHER THAN EXPECTED VITROS CRBM RESULTS BY THE CUSTOMER.

    Description of Event or Problem · 0

    A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT HIGHER THAN EXPECTED VITROS CRBM RESULTS WERE OBTAINED FROM A VITROS THERAPEUTIC DRUG MONITORING (TDM) PERFORMANCE VERIFIER (PV) WHEN PROCESSING A DIAGNOSTIC PRECISION TEST USING VITROS CHEMISTRY PRODUCTS CRBM SLIDES LOT 3912-0119-9653 ON A VITROS 5600 INTEGRATED SYSTEM. VITROS TDM PV III LOT X1172 VITROS CRBM RESULTS OF >84.6, >84.6, >84.6, >84.6, >84.6, >84.6, >84.6, >84.6, >84.6, >84.6, >84.6, >84.6, >84.6, >84.6, >84.6, >84.6 AND >84.6 UMOL/L VS THE EXPECTED RESULT OF 61.1 UMOL/L BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED ON PATIENT SAMPLES. THE HIGHER THAN EXPECTED VITROS CRBM RESULTS WERE OBTAINED WHEN PROCESSING A CONTROL FLUID. NO RESULTS WERE REPORTED OUT OF THE LABORATORY. THERE WERE NO REPORTED ALLEGATIONS 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
    1179637 VITROS 5600 INTEGRATED SYSTEM CHEMISTRY ANALYZER JJE ORTHO-CLINICAL DIAGNOSTICS, INC. 10758750002740

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown