BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS 4600 CHEMISTRY SYSTEM

    MDR report key: 10658887 · Received October 9, 2020

    Report

    Report Number
    1319681-2020-00096
    Event Type
    Malfunction
    Date Received
    October 9, 2020
    Date of Event
    September 11, 2020
    Report Date
    October 9, 2020
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT HIGHER THAN EXPECTED VITROS SODIUM (NA+) RESULTS WERE OBTAINED ON A SINGLE PATIENT SAMPLE AND A VITROS PERFORMANCE VERIFIER I FLUID PROCESSED USING A VITROS 4600 CHEMISTRY SYSTEM. THE ASSIGNABLE CAUSE OF THE HIGHER THAN EXPECTED RESULTS ARE DUE TO AN ANALYZER ISSUE. AN ORTHO FIELD ENGINEER OBTAINED SEVERAL FAILED PRECISION RUNS AT THE CUSTOMER SITE. THE FIELD ENGINEER PERFORMED THE FOLLOWING SERVICE ACTIONS: INSTALLED VERSION (B)(4) SOFTWARE. REMOVED AND CLEANED DISPENSE BLADE ASSEMBLY AND PERFORMED MECHANICAL ADJUSTMENTS. INSPECTED THE TIP LOCATOR CAM SPRING AND ADJUSTED THE TENSION HIGHER. REMOVED, INSPECTED AND CLEANED THE PM RING. PERFORMED PM RING V-BEARING ADJUSTMENTS. PERFORMED PM RING STOPPING POSITION ADJUSTMENT; THE VALUE CHANGED FROM 180 TO 220 STEPS, WHICH IS NOW IN THE ACCEPTABLE RANGE OF 195-225 STEPS. PERFORMED THE DISPENSE BLADE TO PM RING AND TIP LOCATOR ADJUSTMENTS. REMOVED THE ERF MODULE AND CLEANED ALL MOVING PARTS. PERFORMED ERF ADJUSTMENTS. PERFORMED ELECTROMETER HEIGHT ADJUSTMENTS. FOLLOWING THE ABOVE SERVICE ACTIONS, ACCEPTABLE WITHIN RUN VITROS NA+ PRECISION RESULTS WERE OBTAINED USING VITROS NA+ LOTS 4224-1020-2788 AND 4228-1029-6492. HISTORICAL QC PROVIDED FOR VITROS NA+ LOT 4224-1020-2788 WAS ACCURATE BUT IMPRECISE PRIOR TO THE DATE OF THE EVENTS, HOWEVER A REAGENT ISSUE IS NOT A LIKELY CAUSE OF THE EVENTS AS THE SAME REAGENT PERFORMED WITHIN EXPECTATION ON AN ALTERNATE VITROS ANALYZER. IN ADDITION, CONTINUAL TRACKING AND TRENDING DOS NOT INDICATE A SYSTEMIC ISSUE WITH VTROS NA+ LOT 4224-1020-2788.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTIONS CENTER (TSC) TO REPORT HIGHER THAN EXPECTED SODIUM (NA+) RESULTS FROM A SINGLE PATIENT SAMPLE AND A VITROS PERFORMANCE VERIFIER (LOT UNKNOWN) THAT WAS PROCESSED USING A VITROS 4600 CHEMISTRY SYSTEM. PATIENT RESULT OF 146.0 MMOL/L VERSUS THE EXPECTED RESULT OBTAINED ON J2 OF 126.0 MMOL/L. VITROS PERFORMANCE VERIFIER I NA+ RESULTS OF 135.5 AND 139.4 MMOL/L VERSUS PVI MIDPOINT VALUES OF ALL AVAILABLE VITROS PVI LOTS (119.8/117.2/118.2/119.0/119.4 MMOL/L). BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED. THE HIGHER THAN EXPECTED VITROS NA+ PATIENT RESULT WAS NOT REPORTED FROM THE LABORATORY. THERE WERE NO ALLEGATIONS OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC. COMPLAINT NUMBERS (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1124054 VITROS 4600 CHEMISTRY SYSTEM CHEMISTRY ANALYZER JJE ORTHO-CLINICAL DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1