BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS 5600 INTEGRATED SYSTEM

    MDR report key: 8396147 · Received March 6, 2019

    Report

    Report Number
    1319681-2019-00020
    Event Type
    Malfunction
    Date Received
    March 6, 2019
    Date of Event
    January 21, 2019
    Report Date
    March 6, 2019
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT HIGHER THAN EXPECTED TSH RESULTS WERE OBTAINED FROM A NON-VITROS (BIORAD) QUALITY CONTROL (QC) FLUID USING VITROS IMMUNODIAGNOSTICS PRODUCTS TSH REAGENT LOT 5736 IN COMBINATION WITH A VITROS 5600 INTEGRATED SYSTEM. AN INSTRUMENT ISSUE IS THE MOST LIKELY ASSIGNABLE CAUSE OF THE EVENT. A VITROS TSH WITHIN RUN PRECISION TEST PERFORMED BY THE CUSTOMER ON THE VITROS 5600 INTEGRATED SYSTEM DID NOT CONTAIN ENOUGH DATA TO ESTABLISH THE ACCEPTABILITY OF THE INSTRUMENT, ALTHOUGH THE OBSERVED RESULTS SUGGEST AN INSTRUMENT ISSUE. THE CUSTOMER WAS ASKED TO PERFORM MAINTENANCE ON THE INSTRUMENT AND REPEAT THE PRECISION TESTING. ALTHOUGH THE PRECISION TESTING HAS NOT BEEN REPEATED, A COMPARISON OF RESULTS FOR THE ANEMIA CONTROL FROM BEFORE AND AFTER THE MAINTENANCE REQUEST, SUGGESTS THAT THE PERFORMANCE OF THE INSTRUMENT HAD BEEN IMPROVED.

    Description of Event or Problem · 1

    A CUSTOMER OBTAINED HIGHER THAN EXPECTED TSH RESULTS FROM A NON-VITROS (BIORAD) QUALITY CONTROL (QC) FLUID USING VITROS IMMUNODIAGNOSTICS PRODUCTS TSH REAGENT LOT 5736 IN COMBINATION WITH A VITROS 5600 INTEGRATED SYSTEM. BIORAD ANEMIA CONTROL FLUID ON VITROS 5600 INTEGRATED SYSTEM 56002966: 0.157, 0.142, AND 0.145 MIU /ML VERSUS EXPECTED RESULT OF 0.090 MIU /ML. BIASED RESULTS OF THE DIRECTION AND MAGNITUDE OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF UNDETECTED. THE HIGHER THAN EXPECTED VITROS TSH RESULTS WERE OBTAINED WHEN THE CUSTOMER WAS PROCESSING A QC FLUID. HOWEVER, THE INVESTIGATION CANNOT CONFIRM THAT PATIENT SAMPLE RESULTS WOULD NOT BE AFFECT IF THE RESULTS WERE TO RECUR UNDETECTED. THERE WAS NO ALLEGATION OF ACTUAL PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC (ORTHO). COMPLAINT NUMBERS (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    190971 VITROS 5600 INTEGRATED SYSTEM CHEMISTRY ANALYZER JJE ORTHO-CLINICAL DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    0