BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS CHEMISTRY PRODUCTS VALP REAGENT

    MDR report key: 18893769 · Received March 13, 2024

    Report

    Report Number
    1319808-2024-00007
    Event Type
    Malfunction
    Date Received
    March 13, 2024
    Date of Event
    February 15, 2024
    Report Date
    March 12, 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 PERFORMANCE VERIFIER (TDM PV) FLUID USING VITROS CHEMISTRY PRODUCTS VALP REAGENT LOT 2511-32-1764 ON A VITROS XT 7600 INTEGRATED SYSTEM. THE ASSIGNABLE CAUSE OF THE EVENT IS UNKNOWN. HISTORICAL VITROS VALP QUALITY CONTROL WAS WITHIN EXPECTATION, INDICATING THAT AN ISSUE WITH VITROS VALP LOT 2511-32-1764 IS NOT A LIKELY CONTRIBUTOR TO THE EVENT. NO PRECISION TESTING WAS PROCESSED ON THE VITROS XT 7600 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 UNFAMILIAR WITH BASIC SOFTWARE FEATURES AND MAINTENANCE/ ADJUSTMENTS. AN ORTHO FIELD APPLICATION SPECIALIST IS SCHEDULED TO GO THE CUSTOMER SITE TO PERFORM ADDITIONAL TRAINING FOR THE STAFF. IT IS POSSIBLE THAT A PROTOCOL ISSUE CONTRIBUTED TO THE EVENT, ALTHOUGH THIS COULD NOT BE CONFIRMED. 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.

    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 PERFORMANCE VERIFIER (TDM PV) FLUID USING VITROS CHEMISTRY PRODUCTS VALP REAGENT LOT 2511-32-1764 ON A VITROS XT 7600 INTEGRATED SYSTEM. VITROS VALP TDM PV I LOT V1171 RESULT OF 37.2 VERSUS THE EXPECTED RESULT OF 25.05 (CUSTOMERS BASELINE MEAN) 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 QUALITY CONTROL FLUID AND WAS 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 NUMBER (B)(4) AND REPORTABILITY ASSESSMENT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    184606 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