BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS CHEMISTRY PRODUCTS VALP REAGENT

    MDR report key: 9506860 · Received December 20, 2019

    Report

    Report Number
    1319808-2019-00035
    Event Type
    Malfunction
    Date Received
    December 20, 2019
    Date of Event
    November 27, 2019
    Report Date
    December 20, 2019
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    LEG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT HIGHER THAN EXPECTED VITROS VALP RESULTS WERE OBTAINED FROM MULTIPLE PATIENT AND QUALITY CONTROL SAMPLES TESTED ON A VITROS 5600 INTEGRATE SYSTEM. A DEFINITIVE ASSIGNABLE CAUSE COULD NOT BE DETERMINED. THE VITROS 5600 SYSTEM DID NOT LIKELY CONTRIBUTE TO THE EVENT AS THE CUSTOMER PERFORMED WITHIN-RUN PRECISION TESTING USING THE VITROS IGM AND GENT ASSAYS, WITH RESULTS WITHIN THE ACCEPTABLE GUIDELINES. ALTHOUGH THERE ARE NO HISTORICAL QC RESULTS DUE TO THIS BEING A NEW LOT AT THE TIME OF THE EVENT, A VITROS VALP LOT 2511-27-7325 PERFORMANCE ISSUE IS UNLIKELY, AS THE SAME REAGENT LOT AND REAGENT PACK PERFORMED ACCEPTABLY ON AN ALTERNATE ANALYZER. IN ADDITION, A VITROS VALP WITHIN-RUN PRECISION TEST GENERATED RESULTS WITH THE ACCEPTABLE GUIDELINES, INDICATING THAT VITROS VALP LOT 2511-27-7325 WAS PERFORMING AS INTENDED. FINALLY, CONTINUAL TRACKING AND TRENDING OF COMPLAINT DATA HAS NOT IDENTIFIED ANY SIGNALS TO SUGGEST THERE IS A SYSTEMIC QUALITY ISSUE WITH VITROS VALP REAGENT LOT 2511-27-7325.

    Description of Event or Problem · 1

    A CUSTOMER OBSERVED HIGHER THAN EXPECTED VITROS VALP RESULTS OBTAINED FROM PATIENT SAMPLES AND NON-VITROS QC FLUIDS WHEN TESTED USING THE VITROS 5,1 FS SYSTEM. PATIENT 1 SAMPLE RESULT OF 273 UMOL/L VERSUS THE EXPECTED RESULT OF 169 UMOL/.L PATIENT 2 SAMPLE RESULT OF 410 UMOL/L VERSUS THE EXPECTED RESULT OF 299 UMOL/L. PATIENT 3 SAMPLE RESULT OF 971 UMOL/L VERSUS THE EXPECTED RESULT OF 755 UMOL/L BIORAD UNASSAYED MULTIQUAL LOT 47981 L1 RESULT 253.4 VS THE EXPECTED RESULT OF 171.0 UMOL/L. BIORAD UNASSAYED MULTIQUAL LOT 47982 L2 RESULTS 555.1, 577. 8, 583.5, 581.0 VS THE EXPECTED RESULT OF 438.0 UMOL/L. BIORAD UNASSAYED MULTIQUAL LOT 47983 L3 RESULTS 963.1 AND 984.8 VS THE EXPECTED RESULT OF 767.0 UMOL/L. BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF PATIENT SAMPLES WERE AFFECTED. THE HIGHER THAN EXPECTED PATIENT SAMPLE RESULTS WERE REPORTED OUT OF THE LABORATORY, AND CORRECTED REPORTS WERE ISSUED. THERE WAS NO REPORT OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC. (B)(4). THIS REPORT IS NUMBER ONE OF TWO 3500A FORMS FILED FOR THIS EVENT, AS TWO DEVICES WERE INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1302744 VITROS CHEMISTRY PRODUCTS VALP REAGENT IN-VITRO DIAGNOSTIC LEG ORTHO-CLINICAL DIAGNOSTICS 2511-27-7325

    Patients

    Seq Age Sex Outcome Treatment
    1