BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS CHEMISTRY PRODUCTS VANC REAGENT

    MDR report key: 21761206 · Received April 3, 2025

    Report

    Report Number
    1319808-2025-00012
    Event Type
    Malfunction
    Date Received
    April 3, 2025
    Date of Event
    March 13, 2025
    Report Date
    April 2, 2025
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS, INC.
    Product Code
    LEH
    UDI-DI
    10758750006731
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION HAS DETERMINED THAT LOWER AND HIGHER THAN EXPECTED VITROS VANCOMYCIN (VANC) RESULTS WERE OBTAINED FROM A TWO DIFFERENT LEVELS OF VITROS THERAPEUTIC DRUG MONITORING PERFORMANCE VERIFIER (TDM PV) FLUIDS TESTED ON A VITROS XT 7600 INTEGRATED SYSTEM. THE ASSIGNABLE CAUSE OF THE VITROS VANC RESULTS OF 15.55, 15.42, 19.99 AND 20.49 UG/ML WAS A SUBOPTIMAL CALIBRATION. THE ISSUE OCCURRED FOLLOWING CALIBRATION OF VITROS VANC REAGENT LOT 2514-56-2676. THE CALIBRATION RESPONSES AND PARAMETERS OBTAINED FROM THE AFFECTED CALIBRATION APPEARED ATYPICAL TO EXPECTED RESPONSES AND PARAMETERS. ACCEPTABLE PERFORMANCE WAS OBTAINED AFTER PERFORMING AN ADDITIONAL CALIBRATION EVENT WHERE THE CALIBRATION RESPONSES AND PARAMETERS APPEARED ATYPICAL TO EXPECTED RESPONSES AND PARAMETERS. THE CAUSE OF THE SUBOPTIMAL CALIBRATION IS UNKNOWN. THE ASSIGNABLE CAUSE OF THE VITROS VANC RESULTS OF <5.0, <5.0, <5.0, <5.0 UG/ML AND 7.44 UG/ML COULD NOT BE DETERMINED. BASED ON HISTORICAL QUALITY CONTROL RESULTS, A VITROS VANC REAGENT LOT 2514-56-2676 WAS PERFORMING AS INTENDED PRIOR TO THE EVENT. CONTINUAL TRACKING AND TRENDING OF COMPLAINT DATA HAS NOT IDENTIFIED ANY SIGNALS TO SUGGEST THERE IS A SYSTEMIC QUALITY ISSUE WITH VITROS VANC REAGENT LOT 2514-56-2676. THE VITROS VANC RESULTS SHIFTED LOW ON BOTH VITROS TDM PV LEVELS USING PACK ID 3957 AND CALIBRATION CURVE 3751. IT IS NOTED THAT ACCEPTABLE VITROS VANC RESULTS WERE OBTAINED FROM BOTH TDM PV LEVELS PRIOR TO THE EVENT USING PACK ID 3957. IN ADDITION, CALIBRATION CURVE 3751 WAS IN USE SINCE VITROS VANC REAGENT LOT 2514-56-2676 WAS INITIALLY PUT INTO USE ON 30 JANUARY 2025. THIS INDICATES THE EVENT WAS NOT REAGENT PACK OR CALIBRATION DRIVEN. DIAGNOSTIC WITHIN-RUN PRECISION TESTING TO ASSESS THE PERFORMANCE OF THE VITROS XT 7600 INTEGRATED SYSTEM WAS NOT PERFORMED, THEREFORE, AN INSTRUMENT RELATED PERFORMANCE ISSUE CANNOT BE RULED OUT AS CONTRIBUTING TO THE EVENT. HOWEVER, ACCEPTABLE VITROS VANC LOT 2514-56-2676 PERFORMANCE WAS OBTAINED AFTER CALIBRATING WITH AN ALTERNATE REAGENT PACK WITHOUT TAKING ANY ACTION TO OPTIMIZE THE VITROS XT 7600 INTEGRATED SYSTEM. THEREFORE, AN INSTRUMENT RELATED PERFORMANCE ISSUE DID NOT LIKELY CONTRIBUTE TO THE EVENT.

    Description of Event or Problem · 0

    A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT LOWER AND HIGHER THAN EXPECTED VITROS VANC RESULTS WERE OBTAINED FROM A TWO DIFFERENT LEVELS OF VITROS THERAPEUTIC DRUG MONITORING PERFORMANCE VERIFIER (TDM PV) FLUIDS TESTED ON A VITROS XT 7600 INTEGRATED SYSTEM. VITROS TDM PV I LOT C2150 RESULTS OF 15.55, 15.42, 19.99 AND 20.49 UG/ML VS. THE BASELINE MEAN OF 7.73 UG/ML VITROS TDM PV III LOT E2152 RESULTS OF <5.0, <5.0, <5.0, <5.0 UG/ML AND 7.44 UG/ML VS. THE BASELINE MEAN OF 32.0 UG/ML BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED ON PATIENT SAMPLES. THE LOWER AND HIGHER THAN EXPECTED RESULTS WERE OBTAINED FROM NON-PATIENT QUALITY CONTROL FLUIDS. THE CUSTOMER MADE NO ALLEGATION THAT ERRONEOUS PATIENT RESULTS HAD BEEN REPORTED FROM THE LABORATORY. THERE WAS NO ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT IS NUMBER ONE OF THREE MDRS FOR THIS EVENT. THREE 3500A FORMS ARE BEING SUBMITTED FOR THIS EVENT AS THREE DEVICES WERE INVOLVED. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC (ORTHO) COMPLAINT NUMBERS (B)(4) AND REPORTABILITY ASSESSMENT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1735875 VITROS CHEMISTRY PRODUCTS VANC REAGENT IN-VITRO DIAGNOSTICS LEH ORTHO-CLINICAL DIAGNOSTICS, INC. 2514-56-2676 10758750006731

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown