BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS CHEMISTRY PRODUCTS VALP REAGENT

    MDR report key: 20066917 · Received August 26, 2024

    Report

    Report Number
    1319808-2024-00025
    Event Type
    Malfunction
    Date Received
    August 26, 2024
    Date of Event
    July 30, 2024
    Report Date
    August 26, 2024
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS, INC.
    Product Code
    LEG
    UDI-DI
    10758750006748
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION HAS DETERMINED THAT LOWER THAN EXPECTED RESULTS WERE OBTAINED FROM TWO DIFFERENT LEVELS OF VITROS THERAPEUTIC DRUG MONITORING PERFORMANCE VERIFIER (TDM PV) FLUIDS AND TWO DIFFERENT PATIENT SAMPLES USING THE VITROS VALPROIC ACID (VALP) ASSAY AND ONE LEVEL OF VITROS TDM PV FLUID AND ONE DIFFERENT PATIENT SAMPLE USING THE VITROS VANCOMYCIN (VANC) ASSAY. THE AFFECTED SAMPLES WERE TESTED USING VITROS VALP REAGENT LOT 2511-32-1564 AND VITROS VANC LOT 2514-54-1972 WHICH WERE PROCESSED ON A VITROS XT 7600 INTEGRATED SYSTEM. THE ASSIGNABLE CAUSE OF THE LOWER THAN EXPECTED RESULTS FOR EACH ASSAY WAS A REAGENT PACK RELATED ISSUE. THE AFFECTED VITROS VALP RESULTS WERE ISOLATED TO A SINGLE REAGENT PACK, PACK ID 339, AND THE AFFECTED VITROS VANC RESULTS WERE ISOLATED TO A SINGLE REAGENT PACK, PACK ID 9851. THE CAUSE OF THE ISSUE WITH THE AFFECTED REAGENT PACKS IS UNKNOWN, AS BOTH REAGENT PACKS WERE DISCARDED BY THE CUSTOMER AND NO FURTHER INVESTIGATION WAS POSSIBLE. WITH THE EXCEPTION OF THE SINGLE AFFECTED VITROS VALP AND VANC REAGENT PACKS, THERE WAS NO INDICATION THAT VITROS VALP REAGENT LOT 2511-32-1564 OR VITROS VANC REAGENT LOT 2514-54-1972 WAS NOT PERFORMING AS INTENDED, BASED ON HISTORICAL QUALITY CONTROL RESULTS. ACCEPTABLE RESULTS WERE OBTAINED FROM THE SAME VITROS TDM PV FLUIDS USING THE VITROS ACET, CRBM, PHYT AND DGXN ASSAYS, INDICATING THERE WAS NOT A PERFORMANCE ISSUE ASSOCIATED WITH THE VITROS TDM PV FLUIDS IN USE. THERE IS NO INDICATION THE VITROS XT 7600 INTEGRATED SYSTEM MALFUNCTIONED AS ACCEPTABLE VITROS VALP AND VANC PERFORMANCE WAS OBTAINED USING ALTERNATE REAGENT PACKS OF THE SAME LOT NUMBERS WITHOUT PERFORMING ANY ACTIONS TO OPTIMIZE INSTRUMENT PERFORMANCE. THIS INDICATES THE VITROS XT 7600 INTEGRATED SYSTEM DID NOT LIKELY CONTRIBUTE TO THE EVENT.

    Description of Event or Problem · 0

    A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT LOWER THAN EXPECTED RESULTS WERE OBTAINED FROM TWO DIFFERENT LEVELS OF VITROS THERAPEUTIC DRUG MONITORING PERFORMANCE VERIFIER (TDM PV) FLUIDS AND TWO DIFFERENT PATIENT SAMPLES USING THE VITROS VALPROIC ACID (VALP) ASSAY AND ONE LEVEL OF VITROS TDM PV FLUID AND ONE DIFFERENT PATIENT SAMPLE USING THE VITROS VANCOMYCIN (VANC) ASSAY. THE AFFECTED SAMPLES WERE TESTED USING VITROS VALP REAGENT LOT 2511-32-1564 AND VITROS VANC LOT 2514-54-1972 WHICH WERE PROCESSED ON A VITROS XT 7600 INTEGRATED SYSTEM. VITROS VALP REAGENT LOT 2511-32-1564: VITROS TDM PV I LOT Y1734 RESULT OF <10 UG/ML VS. THE EXPECTED RESULT OF 27.0 UG/ML VITROS TDM PV II LOT A1735 RESULT OF 12.2 UG/ML VS. THE EXPECTED RESULT OF 70.0 UG/ML PATIENT 1 SAMPLE VITROS VALP RESULT OF <10 UG/ML VS. THE EXPECTED RESULT OF 99.9 UG/ML PATIENT 2 SAMPLE VITROS VALP RESULT OF <10 UG/ML VS. THE EXPECTED RESULT OF 69.0 UG/ML VITROS VANC REAGENT LOT 2514-54-1972: VITROS TDM PV II LOT A1735 RESULT OF <5 UG/ML VS. THE EXPECTED RESULT OF 21.8 UG/ML PATIENT 4 SAMPLE VITROS VANC RESULT OF <5 UG/ML VS. THE EXPECTED RESULT OF 20.1 UG/ML BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED. NONE OF THE LOWER THAN EXPECTED VITROS VALP OR VITROS VANC PATIENT SAMPLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THERE WAS NO ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT IS NUMBER ONE OF TWO MDRS FOR THIS EVENT. TWO 3500A FORMS ARE BEING SUBMITTED FOR THIS EVENT AS TWO DEVICES WERE INVOLVED. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC (ORTHO) COMPLAINT NUMBER (B)(4) AND REPORTABILITY ASSESSMENT 607101.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    269763 VITROS CHEMISTRY PRODUCTS VALP REAGENT IN-VITRO DIAGNOSTICS LEG ORTHO-CLINICAL DIAGNOSTICS, INC. 2511-32-1564 10758750006748

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown