BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS DT60 II CHEMISTRY SYSTEM

    MDR report key: 2854866 · Received December 3, 2012

    Report

    Report Number
    1319681-2012-00231
    Event Type
    Malfunction
    Date Received
    December 3, 2012
    Date of Event
    November 5, 2012
    Report Date
    December 3, 2012
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT A LOWER THAN EXPECTED VITROS CHOL DT QUALITY CONTROL RESULT WAS 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 VITROS CHOL DT PERFORMANCE WAS OBSERVED. THE ROOT CAUSE OF THIS EVENT IS USER ERROR.

    Description of Event or Problem · 1

    THE CUSTOMER OBTAINED A LOWER THAN EXPECTED VITROS CHOL DT QUALITY CONTROL RESULT WHEN USING THE VITROS DT60 II CHEMISTRY SYSTEM. A VITROS CHOL DT RESULT LESS THAN THE ASSAY MEASURING RANGE OF 50 MG/DL WAS OBTAINED FROM THE VITROS DT CONTROL I FLUID VERSUS THE EXPECTED VALUE OF 144 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. (B)(4).

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1