BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS 4600 CHEMISTRY SYSTEM

    MDR report key: 8823684 · Received July 24, 2019

    Report

    Report Number
    1319681-2019-00064
    Event Type
    Malfunction
    Date Received
    July 24, 2019
    Date of Event
    June 27, 2019
    Report Date
    July 24, 2019
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT A LOWER THAN EXPECTED VITROS VALPROIC ACID (VALP) RESULT WAS OBTAINED FROM A VITROS TDM PERFORMANCE VERIFIER (PV) CONTROL FLUID WHEN RUN ON A VITROS 4600 CHEMISTRY SYSTEM. THE MOST LIKELY ASSIGNABLE CAUSE OF THE LOWER THAN EXPECTED VITROS VALP RESULT WAS AN INSTRUMENT EVENT RELATED ISSUE. AN UNACCEPTABLE WITHIN RUN VITROS VALP PRECISION TEST INDICATED THE VITROS 4600 SYSTEM WAS NOT PERFORMING AS EXPECTED. AN ACCEPTABLE WITHIN RUN VITROS VALP PRECISION TEST WAS OBTAINED AFTER SERVICE ACTIONS PERFORMED BY AN ORTHO FIELD ENGINEER WHICH INCLUDED CHANGING THE MICROIMMUNOASSAY (UIA) PROBOSCIS, CHANGING THE PHOTOMETER LAMP, PERFORMING A WATER BLANK, AND PERFORMING ALL CUVETTE INCUBATOR ADJUSTMENTS. THEREFORE, A VITROS 4600 SYSTEM ISSUE IS THE LIKELY CAUSE OF THE EVENT. THERE IS NO EVIDENCE THAT THE EVENT WAS CAUSED BY A REAGENT ISSUE WITH VITROS VALP LOT 2511-27-7325. IN ADDITION, CONTINUAL TRACKING AND TRENDING OF COMPLAINTS HAS NOT IDENTIFIED ANY SIGNALS THAT WOULD POINT TO A POTENTIAL SYSTEMIC ISSUE WITH VITROS VALP, LOT 2511-27-7325.

    Description of Event or Problem · 1

    A CUSTOMER OBTAINED A LOWER THAN EXPECTED VITROS VALPROIC ACID (VALP) RESULT FROM A VITROS TDM PERFORMANCE VERIFIER (PV) CONTROL FLUID WHEN RUN ON A VITROS 4600 CHEMISTRY SYSTEM. VITROS TDM PVI VALP RESULT OF 16.8 UG/ML VERSUS THE MIDPOINT OF THE ROM (RANGE OF MEAN) 28.6 UG/ML. BIASED RESULTS OF THE DIRECTION AND MAGNITUDE OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF UNDETECTED. THE LOWER THAN EXPECTED VITROS VALP RESULT WAS OBTAINED FROM A NON-PATIENT FLUID. HOWEVER THE INVESTIGATION CANNOT CONCLUDE THAT PATIENT SAMPLE RESULTS WERE NOT AFFECTED OR WOULD NOT BE AFFECTED IF THE EVENT WERE TO RECUR UNDETECTED. ORTHO WAS NOT MADE AWARE OF ANY ALLEGATION OF ACTUAL 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
    617086 VITROS 4600 CHEMISTRY SYSTEM CHEMISTRY ANALYZER JJE ORTHO-CLINICAL DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1