BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS XT 7600 INTEGRATED SYSTEM

    MDR report key: 15002457 · Received July 13, 2022

    Report

    Report Number
    1319681-2022-00030
    Event Type
    Malfunction
    Date Received
    July 13, 2022
    Date of Event
    June 20, 2022
    Report Date
    July 13, 2022
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION HAS DETERMINED THAT HIGHER THAN EXPECTED PHENOBARBITAL (PHBR) RESULTS WERE OBTAINED FROM VITROS THERAPEUTIC DRUG MONITORING PERFORMANCE VERIFIERS USING VITROS CHEMISTRY PRODUCTS PHBR SLIDES LOT 2504-0091-7994 ON A VITROS XT 7600 INTEGRATED SYSTEM. THE ASSIGNABLE CAUSE OF THE HIGHER THAN EXPECTED VITROS PHBR QUALITY CONTROL RESULTS IS USER ERROR AS THE CUSTOMER ERRONEOUSLY SELECTED AN INCORRECT VITROS CAL KIT 9 LOT WHEN PROGRAMMING A CALIBRATION FOR VITROS PHBR ON THE VITROS XT 7600 SYSTEM. THERE IS NO INDICATION THAT THE VITROS XT 7600 INTEGRATED SYSTEM OR THE VITROS PHBR REAGENT MALFUNCTIONED. EMAIL ADDRESS FOR CONTACT OFFICE IN ABOVE IS (B)(6).

    Description of Event or Problem · 0

    THE INVESTIGATION HAS DETERMINED THAT HIGHER THAN EXPECTED PHENOBARBITAL (PHBR) RESULTS WERE OBTAINED FROM VITROS THERAPEUTIC DRUG MONITORING PERFORMANCE VERIFIERS USING VITROS CHEMISTRY PRODUCTS PHBR SLIDES LOT 2504-0091-7994 ON A VITROS XT 7600 INTEGRATED SYSTEM. VITROS TDM I LOT E8706 RESULTS OF 17.8707 AND 17.0093 UG/ML VS AN EXPECTED RESULT OF 12.33 UG/ML VITROS TDM II LOT C8376 RESULTS OF 36.7508, 41.2725 AND 38.6970 UG/ML VS AN EXPECTED RESULT OF 26.74 UG/ML VITROS TDM III LOT G8708 RESULTS OF 77.5546, 78.7206 AND 78.6782 UG/ML VS AN EXPECTED RESULT OF 64.41 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 THAN EXPECTED VITROS PHBR RESULTS WERE OBTAINED FROM QUALITY CONTROL FLUIDS AND NO RESULTS WERE REPORTED FROM THE LABORATORY. NO PATIENT SAMPLES WERE PROCESSED AS THE ASSAY WAS BEING VALIDATED AT THE TIME OF THE EVENT. ORTHO HAS NOT BEEN MADE AWARE OF ANY ALLEGATION 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
    1293489 VITROS XT 7600 INTEGRATED SYSTEM IN-VITRO DIAGNOSTICS JJE ORTHO-CLINICAL DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown