BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS CHEMISTRY PRODUCTS VALP REAGENT

    MDR report key: 17226166 · Received June 29, 2023

    Report

    Report Number
    0001319808-2023-00014
    Event Type
    Malfunction
    Date Received
    June 29, 2023
    Date of Event
    June 5, 2023
    Report Date
    June 28, 2023
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS, INC.
    Product Code
    LEG
    UDI-DI
    10758750006748
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION DETERMINED THAT A LOWER THAN EXPECTED VALPROIC ACID (VALP) RESULT WAS OBTAINED FROM A PATIENT SAMPLE PROCESSED DURING A REAGENT LOT TO LOT CORRELATION USING VITROS CHEMISTRY PRODUCTS VALP REAGENT LOT 2511-31-9784 ON A VITROS 5600 INTEGRATED SYSTEM. THE INVESTIGATION WAS UNABLE TO DETERMINE A DEFINITIVE ASSIGNABLE CAUSE. QUALITY CONTROL RESULTS USING BIORAD CONTROLS AND VITROS TDM PV FLUIDS WERE WITHIN EXPECTATIONS FOR VITROS VALP LOT 2511-31-9784 ON THE DATE OF THE EVENT. ADDITIONALLY, HISTORICAL QC RESULTS FOR THE CUSTOMER¿S PREVIOUS VITROS VALP REAGENT LOT WERE ACCURATE AND PRECISE IN COMBINATION WITH THE VITROS 5600 INTEGRATED SYSTEM INDICATING THAT A REAGENT OR INSTRUMENT RELATED ISSUE ARE NOT LIKELY CONTRIBUTING FACTORS OF THE EVENT. A REAGENT PACK RELATED ISSUE IS NOT A LIKELY CONTRIBUTING FACTOR OF THE EVENT AS ACCEPTABLE QC RESULTS WERE OBTAINED ON THE SAME REAGENT PACK IN WHICH THE LOWER THAN EXPECTED PATIENT SAMPLE RESULTS WERE OBTAINED. CONTINUAL TRACKING AND TRENDING OF COMPLAINTS HAS NOT IDENTIFIED ANY SIGNALS THAT WOULD POINT TO A POTENTIAL SYSTEMIC ISSUE WITH VITROS VALP REAGENT LOT 2511-31-9784.

    Description of Event or Problem · 0

    A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT A LOWER THAN EXPECTED VALPROIC ACID (VALP) RESULT WAS OBTAINED FROM A PATIENT SAMPLE PROCESSED DURING A REAGENT LOT TO LOT CORRELATION USING VITROS CHEMISTRY PRODUCTS VALP REAGENT LOT 2511-31-9784 ON A VITROS 5600 INTEGRATED SYSTEM. PATIENT 2 SAMPLE RESULT OF 35.95 UG/ML VS AN EXPECTED RESULT OF 49.64 UG/ML BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED. THE LOWER THAN EXPECTED RESULT WAS FROM A PATIENT SAMPLE THAT WAS PROCESSED DURING REAGENT LOT TO LOT CORRELATION TESTING AND WAS NOT REPORTED OUTSIDE OF THE LABORATORY. NO ERRONEOUS PATIENT SAMPLE RESULTS WERE REPORTED FROM THE LABORATORY. AT THE TIME OF THIS REPORT, THE CUSTOMER HAS ELECTED TO SEND PATIENT SAMPLES TO AN ALTERNATE SITE FOR VALP TESTING UNTIL TROUBLESHOOTING IS COMPLETE. 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
    1527407 VITROS CHEMISTRY PRODUCTS VALP REAGENT IN-VITRO DIAGNOSTICS LEG ORTHO-CLINICAL DIAGNOSTICS, INC. 6801710 2511-31-9784 10758750006748

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown