BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS DT60 II CHEMISTRY SYSTEM

    MDR report key: 3485704 · Received November 25, 2013

    Report

    Report Number
    1319681-2013-00196
    Event Type
    Malfunction
    Date Received
    November 25, 2013
    Date of Event
    October 28, 2013
    Report Date
    November 25, 2013
    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 UNEXPECTED VITROS ALKP DT, CHOL DT, AND CA DT QUALITY CONTROL RESULTS WERE OBTAINED ON A VITROS DT60 II CHEMISTRY SYSTEM. THE INVESTIGATION DETERMINED THAT THE CAUSE OF THIS EVENT WAS A USER-INDUCED SLIDE TRACKING ERROR, WHICH IS A REPORTABLE MALFUNCTION FOR THE VITROS DT60 II CHEMISTRY SYSTEM. INFORMATION FROM SECTION 8.3 OF THE VITROS DT60 II OPERATOR¿S MANUAL (31-JULY-2010 REVISION) DESCRIBING THE POTENTIAL CAUSES OF A SLIDE TRACKING ERROR WAS REVIEWED WITH THE CUSTOMER. FOLLOWING ACTIONS TO RESOLVE A SLIDE TRACKING ERROR, ACCEPTABLE QUALITY CONTROL RESULTS WERE OBTAINED. THE ROOT CAUSE OF THIS EVENT IS USER ERROR.

    Description of Event or Problem · 1

    THE CUSTOMER OBTAINED UNEXPECTED VITROS ALKP DT, CHOL DT, AND CA DT QUALITY CONTROL RESULT WHEN USING THE VITROS DT60 II CHEMISTRY SYSTEM. WHEN RUNNING THE VITROS DT CONTROL II FLUID, A VITROS ALKP DT RESULT OF 274 U/L WAS OBTAINED VERSUS THE EXPECTED VALUE OF 401 U/L, A VITROS CHOLD DT RESULT OF 5.42 MMOL/L WAS OBTAINED VERSUS THE EXPECTED VALUE OF 6.2 MMOL/L, AND VITROS CA DT RESULTS OF >14.0 AND 2.90 MG/DL WERE OBTAINED VERSUS THE EXPECTED VALUE OF 11.7 MG/DL. NO PATIENT SAMPLES WERE RUN DURING THE TIME FRAME OF THE EVENT. THERE WAS NO REPORT OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC. COMPLAINT NUMBER (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    613117 VITROS DT60 II CHEMISTRY SYSTEM CHEMISTRY ANALYZER JJE ORTHO-CLINICAL DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1