BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS CHEMISTRY PRODUCTS VALP REAGENT

    MDR report key: 19600583 · Received June 24, 2024

    Report

    Report Number
    1319808-2024-00016
    Event Type
    Malfunction
    Date Received
    June 24, 2024
    Date of Event
    May 26, 2024
    Report Date
    June 24, 2024
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS, INC.
    Product Code
    LEG
    UDI-DI
    10758750006748
    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 A HIGHER THAN EXPECTED VALPROIC ACID (VALP) RESULT WAS OBTAINED FROM A VITROS THERAPEUTIC DRUG MONITORING (TDM) PERFORMANCE VERIFIER PROCESSED USING VITROS CHEMISTRY PRODUCTS VALP REAGENT LOT 2511-33-2028 ON A VITROS XT 7600 INTEGRATED SYSTEM. THE INVESTIGATION WAS UNABLE TO DETERMINE A DEFINITIVE ASSIGNABLE CAUSE. BASED ON HISTORICAL QC RESULTS A VITROS VALP REAGENT LOT 2511-33-2028 RELATED ISSUE IS NOT A LIKELY CONTRIBUTOR TO THE EVENT. ADDITIONALLY, CONTINUAL TRACKING AND TRENDING OF COMPLAINTS HAS NOT IDENTIFIED ANY SIGNALS THAT WOULD POINT TO A POTENTIAL SYSTEMIC ISSUE WITH VITROS VALP REAGENT LOT 2511-33-2028. AS PRECISION TESTING WAS NOT PERFORMED ON THE VITROS XT 7600 SYSTEM, AN INSTRUMENT RELATED ISSUE CANNOT BE RULED OUT AS A CONTRIBUTING FACTOR OF THE EVENT. HOWEVER, THERE WAS NO EVIDENCE SUGGESTING THAT THE VITROS XT 7600 SYSTEM MALFUNCTIONED. IN ADDITION, AS NO DETAILS OF THE CUSTOMERS INITIAL PROTOCOL WHEN PREPARING AND HANDLING THE VITROS TDM FLUIDS WAS PROVIDED, AN ISSUE RELATED TO IMPROPER PROTOCOL CANNOT BE COMPLETELY RULED OUT AS A CONTRIBUTING FACTOR OF THE EVENT. THE CUSTOMER REPROCESSED THE SAME VIALS OF VITROS TDM FLUIDS AND OBTAINED EXPECTED RESULTS. THEREFORE, AN ISSUE RELATED THE VITROS TDM FLUID IS NOT A LIKELY CONTRIBUTOR OF THE EVENT. HOWEVER, PRIOR TO TESTING, THE CUSTOMER HAD RECALIBRATED VITROS VALP LOT 2511-33-2028 USING A FRESH REAGENT PACK. THEREFORE, A SUBOPTIMAL CALIBRATION FROM 26 MAY 2024 OR A REAGENT PACK RELATED ISSUE CANNOT BE RULED OUT AS CONTRIBUTORS OF THE EVENT.

    Description of Event or Problem · 0

    A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT A HIGHER THAN EXPECTED VALPROIC ACID (VALP) RESULT WAS OBTAINED FROM A VITROS THERAPEUTIC DRUG MONITORING (TDM) PERFORMANCE VERIFIER PROCESSED USING VITROS CHEMISTRY PRODUCTS VALP REAGENT LOT 2511-33-2028 ON A VITROS XT 7600 INTEGRATED SYSTEM. VITROS TDM I LOT Y1734 RESULT OF 39.0 UG/ML VS AN EXPECTED RESULT OF 27.6 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 RESULT WAS FROM A NON-PATIENT FLUID AND WAS NOT REPORTED OUTSIDE OF THE LABORATORY. THE CUSTOMER DID NOT CONFIRM WHEN REQUESTED WHETHER PATIENT SAMPLE RESULTS WERE AFFECTED OR QUESTIONED. THERE WAS NO REPORTED ALLEGATION 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
    2102968 VITROS CHEMISTRY PRODUCTS VALP REAGENT IN-VITRO DIAGNOSTICS LEG ORTHO-CLINICAL DIAGNOSTICS, INC. 2511-33-2028 10758750006748

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown