BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS 5600 INTEGRATED SYSTEM

    MDR report key: 8129300 · Received December 4, 2018

    Report

    Report Number
    1319681-2018-00122
    Event Type
    Malfunction
    Date Received
    December 4, 2018
    Date of Event
    November 6, 2018
    Report Date
    December 4, 2018
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION FOUND MULTIPLE HIGHER THAN EXPECTED VITROS PHENYTOIN RESULTS OBTAINED DURING A PRECISION TEST USING VITROS CHEMISTRY PRODUCTS PHENYTOIN (PHYT) SLIDES ALONG WITH VITROS THERAPEUTIC DRUG MONITORING PERFORMANCE VERIFIER III (TDM PVIII) ON A VITROS 5600 INTEGRATED SYSTEM. THE INVESTIGATION CONCLUDED THAT THE CAUSE OF THE IMPRECISE VITROS PHYT RESULTS WAS MOST LIKELY INSTRUMENT RELATED. THE RESULTS OF A PRE-SERVICE WITHIN-RUN VITROS PHYT PRECISION TEST WERE UNACCEPTABLE ACCORDING TO ORTHO GUIDELINES, INDICATING THE VITROS 5600 INTEGRATED SYSTEM WAS NOT PERFORMING AS INTENDED WHEN PROCESSING VITROS PHYT SLIDES. ACCEPTABLE WITHIN-RUN PRECISION VITROS PHYT RESULTS WERE ATTAINED AFTER AN ORTHO FIELD ENGINEER COMPLETED SERVICE ACTIONS INCLUDING REPLACING THE IMMUNORATE WASH FLUID PUMP, REPLACING A DAMAGED SLIDE ALIGN GUIDE BEARING AND PERFORMING ALL NECESSARY ADJUSTMENTS. THERE HAVE BEEN NO FURTHER REPORTS OF IMPRECISE VITROS PHYT RESULTS FROM THE SITE SINCE SERVICE WAS COMPLETED INDICATING THAT THE INSTRUMENT WAS RETURNED TO OPTIMAL PERFORMANCE.

    Description of Event or Problem · 1

    SEVERAL HIGHER THAN EXPECTED VITROS PHYT RESULTS WERE OBTAINED FROM A PRECISION RUN TEST USING VITROS CHEMISTRY PRODUCTS PHENYTOIN (PHYT) SLIDES WITH VITROS THERAPEUTIC DRUG MONITORING PERFORMANCE VERIFIER III (TDM PVIII) ON A VITROS 5600 INTEGRATED SYSTEM. VITROS PHYT RESULTS OF 33.4, 32.9, 32.1, 31.8, 31.7, 30.4, 30.3, 30.1, 29.9 AND 29.5 UG/ML VERSUS THE EXPECTED RESULT OF 24.3 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. NO PATIENT SAMPLES WERE QUESTIONED DURING THE TIMEFRAME OF THIS EVENT. IT CANNOT BE CONCLUDED THAT PATIENT SAMPLE RESULTS WERE NOT AND WOULD NOT BE AFFECTED IF THE EVENT WERE TO RECUR UNDETECTED. HOWEVER, THERE HAS BEEN NO ALLEGATION OF ANY PATIENT HARM AS A RESULT OF THE EVENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    967131 VITROS 5600 INTEGRATED SYSTEM CHEMISTRY ANALYZER JJE ORTHO-CLINICAL DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1