BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS CHEMISTRY PRODUCTS VALP REAGENT

    MDR report key: 19331409 · Received May 16, 2024

    Report

    Report Number
    1319808-2024-00015
    Event Type
    Malfunction
    Date Received
    May 16, 2024
    Date of Event
    April 17, 2024
    Report Date
    May 13, 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 HIGHER AND LOWER THAN EXPECTED VALPROIC ACID RESULTS WERE OBTAINED FROM TWO LEVELS OF VITROS TDM PERFORMANCE VERIFIER (PV) FLUIDS USING VITROS CHEMISTRY PRODUCTS VALP REAGENT LOT 2511-32-1764 ON A VITROS XT7600 INTEGRATED SYSTEM. THE ASSIGNABLE CAUSE OF THE EVENT CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED. ALTHOUGH LIMITED VITROS VALP QUALITY CONTROL RESULTS WERE PROVIDED, THE RESULTS PROVIDED BY THE CUSTOMER BOTH BEFORE AND AFTER THE EVENT WERE WITHIN EXPECTATION, INDICATING THAT AN ISSUE WITH VITROS VALP LOT 2511-32-1764 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 LOT 2511-32-1764. NO PRECISION TESTING WAS PROCESSED ON THE VITROS XT7600 SYSTEM AT THE TIME OF THE EVENT OR THIS REPORT. THEREFORE, AN INSTRUMENT ISSUE CANNOT BE CONFIRMED OR RULED OUT AS A CONTRIBUTOR TO THE EVENT. THE CUSTOMER WAS QUESTIONED REGARDING THEIR TYPICAL VITROS PV FLUID HANDLING PROTOCOL, HOWEVER, DID NOT PROVIDE ANY OF THIS INFORMATION. A PROTOCOL RELATED ISSUE CANNOT BE RULED OUT AS A CONTRIBUTOR TO THE EVENT. RECALIBRATION FOR VITROS VALP LOT 2511-32-1764 WAS PERFORMED AND ACCEPTABLE QC RESULTS WERE OBTAINED POST CALIBRATION. HOWEVER, IT IS UNKNOWN IF THE NEW CALIBRATION AND SUBSEQUENT QC RUNS WERE PERFORMED USING THE SAME PACK THAT INITIALLY PRODUCED THE UNEXPECTED RESULTS, THEREFORE A PACK-RELATED ISSUE CANNOT BE CONFIRMED OR RULED OUT AS A CONTRIBUTOR TO THE EVENT.

    Description of Event or Problem · 0

    A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT HIGHER AND LOWER THAN EXPECTED VALPROIC ACID (VALP) RESULTS WERE OBTAINED FROM TWO LEVELS OF VITROS THERAPEUTIC DRUG MONITORING (TDM) PERFORMANCE VERIFIER (PV) FLUIDS USING VITROS CHEMISTRY PRODUCTS VALP REAGENT LOT 2511-32-1764 ON A VITROS XT7600 INTEGRATED SYSTEM. VITROS VALP TDM PVI LOT Y1734 RESULT OF 46.5 UG/ML AND 44.0 UG/ML VERSUS THE EXPECTED RESULT OF 27.6 UG/ML VITROS VALP TDM PVIII LOT B1736 RESULT OF 94.2 UG/ML VERSUS THE EXPECTED RESULT OF 120.6 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 AND LOWER THAN EXPECTED RESULTS WERE FROM TWO LEVELS OF VITROS QUALITY CONTROL FLUID AND WERE NOT REPORTED OUTSIDE OF THE LABORATORY. THE CUSTOMER CONFIRMED THAT PATIENT SAMPLES WERE NOT PROCESSED DURING THE TIMEFRAME OF THE EVENT. THERE WAS NO ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC (ORTHO) COMPLAINT NUMBERS (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    514012 VITROS CHEMISTRY PRODUCTS VALP REAGENT IN-VITRO DIAGNOSTICS LEG ORTHO-CLINICAL DIAGNOSTICS, INC. 2511-32-1764 10758750006748

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown