BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS 5600 INTEGRATED SYSTEM

    MDR report key: 8686846 · Received June 11, 2019

    Report

    Report Number
    1319681-2019-00053
    Event Type
    Malfunction
    Date Received
    June 11, 2019
    Date of Event
    May 15, 2019
    Report Date
    June 11, 2019
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT LOWER AND HIGHER THAN EXPECTED VITROS PHENYTOIN RESULTS WERE OBTAINED FROM A VITROS THERAPEUTIC DRUG MONITORING PERFORMANCE VERIFIER III (TDM PVIII) USING VITROS CHEMISTRY PRODUCTS PHENYTOIN (PHYT) SLIDES IN COMBINATION WITH A VITROS 5600 INTEGRATED SYSTEM. THE INVESTIGATION CONCLUDED THAT THE MOST LIKELY CAUSE OF THE IMPRECISE VITROS PHYT RESULTS WAS AN INSTRUMENT RELATED ISSUE. 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. A FIELD ENGINEER VISITED THE SITE AND OPTIMIZED THE WASH FLUID METERING MODULE. A POST SERVICE WITHIN-RUN VITROS PHYT PRECISION TEST YIELDED RESULTS THAT WERE WITHIN ACCEPTABLE GUIDELINES. BASED ON HISTORICAL QUALITY CONTROL RESULTS A VITROS PHYT SLIDE LOT 2618-0169-6207 PERFORMANCE ISSUE IS NOT A LIKELY CONTRIBUTOR TO THE EVENT. FURTHERMORE, ONGOING TRACKING AND TRENDING OF COMPLAINT DATA HAS NOT IDENTIFIED ANY SIGNALS TO SUGGEST THERE IS A SYSTEMIC QUALITY ISSUE WITH VITROS PHYT SLIDE LOT 2618-0169-6207.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED IMPRECISE VITROS PHYT RESULTS OBTAINED FROM A VITROS THERAPEUTIC DRUG MONITORING PERFORMANCE VERIFIER III (TDM PVIII) USING VITROS CHEMISTRY PRODUCTS PHENYTOIN (PHYT) SLIDES ON A VITROS 5600 INTEGRATED SYSTEM. VITROS PHYT RESULTS OF 20.74, 35.82 AND 33.56 UG/ML VERSUS THE BASELINE MEAN OF 26.10 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 IMPRECISE RESULTS STEMMED FROM A QUALITY CONTROL FLUID AND NO PATIENT RESULTS WERE AFFECTED. HOWEVER, IT CANNOT BE CONCLUDED THAT PATIENT SAMPLE RESULTS WOULD NOT BE AFFECTED IF THE EVENT WERE TO RECUR UNDETECTED. THERE HAS BEEN NO ALLEGATION OF PATIENT HARM AS A RESULT OF THE EVENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC. COMPLAINT NUMBER (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    483094 VITROS 5600 INTEGRATED SYSTEM CHEMISTRY ANALYZER JJE ORTHO-CLINICAL DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1