BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS CHEMISTRY PRODUCTS PHYT SLIDES

    MDR report key: 7493677 · Received May 8, 2018

    Report

    Report Number
    1319809-2018-00080
    Event Type
    Malfunction
    Date Received
    May 8, 2018
    Date of Event
    April 12, 2018
    Report Date
    May 8, 2018
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    DIP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT HIGHER THAN EXPECTED VITROS PHYT RESULTS WERE OBTAINED FOR A NON-VITROS BIORAD CONTROL FLUID AND A VITROS PERFORMANCE VERIFIER CONTROL FLUID PROCESSED USING VITROS CHEMISTRY PRODUCTS PHYT SLIDES LOT 2615-0166-7390 ON A VITROS 5600 INTEGRATED SYSTEM (S/N (B)(4)). A DEFINITIVE ASSIGNABLE CAUSE COULD NOT BE DETERMINED, HOWEVER, A SUB-OPTIMAL CALIBRATION OR AN INSTRUMENT RELATED ISSUE CANNOT BE RULED OUT AS CONTRIBUTING TO THE EVENT. DURING SERVICE OF THE INSTRUMENT IT WAS FOUND THAT THE IWF TUBING WAS KINKED, WHICH COULD AFFECT THE IWF VOLUME DURING A WASH CYCLE. THE CUSTOMER HAD CALIBRATED BETWEEN THE INITIAL EVENT AND THE DATE THE IWF TUBING WAS REPLACED, THEREFORE, A SUBOPTIMAL CALIBRATION EVENT COULD HAVE CONTRIBUTED TO THE HIGHER THAN EXPECTED VITROS PHYT RESULTS. ACCEPTABLE PERFORMANCE WAS OBTAINED AFTER THE IWF TUBING WAS REPLACED AND RECALIBRATION OF VITROS PHYT SLIDE LOT 2615-0166-7390 PERFORMED.

    Description of Event or Problem · 1

    A CUSTOMER OBTAINED HIGHER THAN EXPECTED VITROS PHYT RESULTS FOR A NON-VITROS BIORAD CONTROL FLUID AND A VITROS PERFORMANCE VERIFIER CONTROL FLUID PROCESSED USING VITROS CHEMISTRY PRODUCTS PHYT SLIDES ON A VITROS 5600 INTEGRATED SYSTEM. BIORAD LEVEL 3, LOT 40930, RESULT OF 25.35 UG/ML VS. THE EXPECTED RESULT OF 20.92 UG/ML. VITROS PV II, LOT P5115, RESULTS OF 27.57 AND 27.71 UG/ML VERSUS THE EXPECTED RESULT OF 22.6 UG/ML. BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF PATIENT SAMPLES WERE AFFECTED. PATIENT SAMPLES WERE NOT TESTED AS THE QUALITY CONTROL RESULTS WERE NOT ACCEPTABLE, AND ORTHO WAS NOT MADE AWARE OF ANY ALLEGATION OF PATIENT HARM. HOWEVER, THE INVESTIGATION CANNOT CONCLUDE PATIENT RESULTS WOULD NOT BE AFFECTED IF THE EVENT WERE TO RECUR UNDETECTED. (B)(4). THIS REPORT IS NUMBER THREE OF THREE MDR¿S FOR THIS EVENT. THREE 3500A FORMS ARE BEING SUBMITTED FOR THIS EVENT AS THREE DEVICES WERE INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    336375 VITROS CHEMISTRY PRODUCTS PHYT SLIDES IN-VITRO DIAGNOSTIC DIP ORTHO-CLINICAL DIAGNOSTICS 2615-0166-7390

    Patients

    Seq Age Sex Outcome Treatment
    1