BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS 4600 CHEMISTRY SYSTEM

    MDR report key: 13690600 · Received March 8, 2022

    Report

    Report Number
    1319681-2022-00010
    Event Type
    Malfunction
    Date Received
    March 8, 2022
    Date of Event
    February 7, 2022
    Report Date
    March 7, 2022
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION DETERMINED THAT HIGHER THAN EXPECTED VITROS VALPROIC ACID (VALP) RESULTS WERE OBTAINED FROM TWO DIFFERENT VITROS THERAPEUTIC DRUG MONITORING PERFORMANCE VERIFIER (TDM PV) FLUIDS TESTED ON A VITROS 4600 CHEMISTRY SYSTEM. THE ASSIGNABLE CAUSE OF THE EVENT IS AN INSTRUMENT RELATED PERFORMANCE ISSUE. THE VITROS VALP QUALITY CONTROL RESULTS SHIFTED HIGH AFTER A SERVICE EVENT PREVIOUSLY PERFORMED BY AN ORTHO FIELD ENGINEER (FE). WITHIN-LAB PRECISION TESTING WAS OUTSIDE OF VITROS ACCEPTANCE CRITERIA FOR THE VITROS VALP ASSAY. AN ORTHO FE PERFORMED SERVICE ACTIONS TO THE CUVETTE INCUBATOR, CUVATIP ASPIRATE AND METERING TRUCKS. ACCEPTABLE PERFORMANCE WAS OBTAINED FOLLOWING SERVICE ACTIONS INDICATING THE ISSUE WAS RESOLVED. (B)(4).

    Description of Event or Problem · 0

    THE INVESTIGATION DETERMINED THAT HIGHER THAN EXPECTED VITROS VALPROIC ACID (VALP) RESULTS WERE OBTAINED FROM TWO DIFFERENT VITROS THERAPEUTIC DRUG MONITORING PERFORMANCE VERIFIER (TDM PV) FLUIDS TESTED ON A VITROS 4600 CHEMISTRY SYSTEM. VITROS TDM PV I LOT B8375 VALP RESULTS OF 34.94 AND 35.2 G/ML VS. THE BASELINE MEAN VALUE OF 24.68 G/ML .VITROS TDM PV III LOT G8708 VALP RESULTS OF 140.17, 142.76, 146.89, 145.42, >150.0, >150.0, >150.0 AND 147.1 G/ML VS. THE BASELINE MEAN VALUE OF 113.1 G/ML. BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED ON PATIENT SAMPLES. THE CUSTOMER MADE NO INDICATIONS THAT PATIENT SAMPLES WERE AFFECTED AND THERE WAS NO REPORTED ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC (ORTHO) COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1338846 VITROS 4600 CHEMISTRY SYSTEM CHEMISTRY ANALYZER JJE ORTHO-CLINICAL DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown