BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS XT 3400 CHEMISTRY SYSTEM

    MDR report key: 10266840 · Received July 13, 2020

    Report

    Report Number
    1319681-2020-00045
    Event Type
    Malfunction
    Date Received
    July 13, 2020
    Date of Event
    June 15, 2020
    Report Date
    July 13, 2020
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT LOWER THAN EXPECTED VITROS PHYT RESULTS WERE OBTAINED FROM VITROS TDM PV III LOT W7852 FLUID AND AN INTERNAL PRECISION POOL PP5 FLUID, LOT 201642-03 USING THREE DIFFERENT VITROS PHYT SLIDE LOTS TESTED ON A VITROS XT3400 CHEMISTRY SYSTEM. THE MOST LIKELY ASSIGNABLE CAUSE OF THE EVENT IS AN INSTRUMENT ISSUE RELATED TO INCOMPLETE IR WASH OF THE AFFECTED PHYT SLIDES. AN ORTHO SERVICE ENGINEER REVIEWED THE DIGITAL READS OF THE SLIDES THAT GENERATED THE LOWER THAN EXPECTED RESULTS AND OBSERVED SPOTS IN THE READING FRAME OF THE SLIDES THAT WERE DUE TO AN INCOMPLETE IR WASH. THE CAUSE OF THE INCOMPLETE IR WASH IS UNKNOWN; HOWEVER, A DAMAGED IR WASH TIP IS THE MOST LIKELY CAUSE. ACCEPTABLE VITROS PHYT PERFORMANCE WAS OBTAINED AFTER REPLACING THE IR WASH TIP AS PART OF ROUTINE MAINTENANCE, WITH NO OTHER ACTIONS TAKEN TO MITIGATE THE ISSUE. THE IR WASH SUBSYSTEM OF THE VITROS XT 3400 SYSTEM WAS SHOWN TO BE PERFORMING AS EXPECTED BY AN ORTHO SE PERFORMING AN ACCEPTABLE SPOT OFF CENTER PERFORMANCE TEST. IT IS UNLIKELY THE VITROS PHYT SLIDE LOTS IN USE CONTRIBUTED TO THE EVENT AS THREE DIFFERENT SLIDE LOTS WERE AFFECTED. IN ADDITION, REPEAT TESTING OF THE SAME TDM PV III W7852 AND PP5 FLUIDS AFTER REPLACING THE IR WASH TIP GENERATED ACCEPTABLE RESULTS, RULING OUT BOTH A PHYT SLIDE RELATED ISSUE AND A FLUID RELATED ISSUE. CONTINUAL TRACKING AND TRENDING OF VITROS PHYT COMPLAINTS HAS NOT IDENTIFIED ANY SIGNALS THAT WOULD POINT TO A POTENTIAL SYSTEMIC ISSUE WITH THE THREE AFFECTED VITROS PHYT SLIDE LOTS.

    Description of Event or Problem · 1

    ON (B)(6) 2020, DURING AN INTERNAL PRECISION VALIDATION TEST, AN ORTHO CLINICAL DIAGNOSTICS (ORTHO) SCIENTIST DETERMINED THAT NON-REPRODUCIBLE LOWER THAN EXPECTED VITROS PHENYTOIN (PHYT) QUALITY CONTROL RESULTS WERE OBTAINED FROM A SINGLE LEVEL OF VITROS THERAPEUTIC DRUG MONITORING PERFORMANCE VERIFIER (TDM PV) QUALITY CONTROL FLUID AND A SINGLE LEVEL OF INTERNAL MANUFACTURED POOLED PRECISION FLUID (PP5) USING THREE DIFFERENT VITROS PHYT SLIDE LOTS TESTED ON A VITROS XT3400 CHEMISTRY SYSTEM. VITROS PHYT SLIDE LOT 2620-0173-8313: VITROS TDM PV III LOT W7852 PHYT RESULTS OF 19.6 AND 18.5 UG/ML VS THE EXPECTED RESULT OF 26.5 UG/ML. VITROS PHYT SLIDE LOT 2620-0173-8314: VITROS TDM PV III LOT W7852 PHYT RESULTS OF 19.4 AND 19.1 UG/ML VS THE EXPECTED RESULT OF 26.5 UG/ML. VITROS PHYT SLIDE LOT 2620-0173-9899: VITROS INTERNAL PRECISION POOL PP5 LOT 201642-03 PHYT RESULT OF 23.4 UG/ML VS THE EXPECTED RESULT OF 30.5 UG/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 TEST WAS AN INTERNAL TEST FOR PRECISION VALIDATION AND NOT USED TO REPORT PATIENT SAMPLE RESULTS. THERE WAS NO ALLEGATION OF PATIENT HARM. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC. NONCONFORMANCE (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    726502 VITROS XT 3400 CHEMISTRY SYSTEM CHEMISRY ANALYZER JJE ORTHO-CLINICAL DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1