BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 9

    MDR report key: 20192263 · Received September 11, 2024

    Report

    Report Number
    1319808-2024-00029
    Event Type
    Malfunction
    Date Received
    September 11, 2024
    Date of Event
    August 3, 2024
    Report Date
    September 11, 2024
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS, INC.
    Product Code
    JIT
    UDI-DI
    10758750005031
    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 DETERMINED THAT BOTH LOWER AND HIGHER THAN EXPECTED VITROS THERAPEUTIC DRUG MONITORING (TDM) PERFORMANCE VERIFIER (PV) QUALITY CONTROL RESULTS WERE OBTAINED WHEN PROCESSING TWO DIFFERENT VITROS CARBAMAZEPINE (CRBM) SLIDE LOTS USING A VITROS XT 7600 INTEGRATED SYSTEM. THE INVESTIGATION CONCLUDES THAT THE LIKELY CAUSE OF THIS EVENT WAS SUBOPTIMAL CALIBRATIONS. THE ISSUE OCCURRED FOLLOWING CALIBRATION OF NEW VITROS CRBM SLIDE LOTS. THE CALIBRATION RESPONSES AND PARAMETERS OBTAINED FROM ALL THE AFFECTED CALIBRATIONS APPEARED ATYPICAL TO EXPECTED RESPONSES AND PARAMETERS. NO INFORMATION WAS PROVIDED CONCERNING THE HANDLING OF THE CALIBRATOR FLUIDS PRIOR TO CALIBRATING. THEREFORE, IMPROPER CALIBRATOR HANDLING PROTOCOL CANNOT BE RULED OUT AS CONTRIBUTING TO THE EVENT. A SUCCESSFUL WITHIN RUN DIAGNOSTIC PRECISION TEST CONCLUDES THE VITROS XT 7600 SYSTEM WAS PERFORMING AS EXPECTED AND AN INSTRUMENT ISSUE HAS BEEN RULED OUT AS A CONTRIBUTOR TO THE EVENT. CONTINUAL TRACKING AND TRENDING OF COMPLAINTS HAS NOT IDENTIFIED ANY SIGNALS THAT WOULD POINT TO A POTENTIAL ISSUE WITH VITROS CRBM LOTS 3916-0125-1727 OR 3916-0125-1782.

    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 THERAPEUTIC DRUG MONITORING (TDM) PERFORMANCE VERIFIER (PV) QUALITY CONTROL RESULTS WERE OBTAINED WHEN PROCESSING TWO DIFFERENT VITROS CARBAMAZEPINE (CRBM) SLIDE LOTS USING A VITROS XT 7600 INTEGRATED SYSTEM. VITROS CRBM SLIDE LOT 3916-0125-1727: VITROS TDM PV I Y1734 RESULTS OF 7.95 AND 7.84 UG/ML VERSUS THE BASELINE MEAN VALUE OF 4.82 UG/ML VITROS TDM PV III B1736 RESULTS OF 8.88, >20, >20, >20 AND >20 UG/ML VERSUS THE BASELINE MEAN VALUE OF 13.32 UG/ML VITROS CRBM SLIDE LOT 3916-0125-1782: VITROS TDM PV III B1736 RESULTS OF 9.31, 18.31, 17.92, 17.63, 18.52, 18.87, 17.4, 18.1, 17.8, 17.9, 18.4 AND 17.6 UG/ML VERSUS THE BASELINE MEAN VALUE OF 13.32 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 HIGHER AND LOWER THAN EXPECTED RESULTS WERE OBTAINED FROM NON-PATIENT QUALITY CONTROL FLUIDS. THE CUSTOMER MADE NO ALLEGATION THAT PATIENT RESULTS WERE AFFECTED OR REPORTED FROM THE LABORATORY. THERE WAS NO ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT IS NUMBER ONE OF SIX MDRS FOR THIS EVENT. SIX 3500A FORMS ARE BEING SUBMITTED FOR THIS EVENT AS SIX 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
    567388 VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 9 IN-VITRO DIAGNOSTICS JIT ORTHO-CLINICAL DIAGNOSTICS, INC. 0963 10758750005031

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown