BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS DT60 II CHEMISTRY SYSTEM

    MDR report key: 3201517 · Received July 2, 2013

    Report

    Report Number
    1319681-2013-00137
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Date of Event
    June 9, 2013
    Report Date
    July 2, 2013
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT UNEXPECTED VITROS NBIL 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. 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 NBIL DT PERFORMANCE WAS OBSERVED. THE ROOT CAUSE OF THIS EVENT IS USER ERROR.

    Description of Event or Problem · 1

    THE CUSTOMER OBTAINED UNEXPECTED VITROS NBIL DT QUALITY CONTROL RESULTS (QC FLUID Y2363 = 1.1, 1.3 VS. AN EXPECTED RESULT = 13.9 MG/DL) WHEN USING THE VITROS DT60 II CHEMISTRY SYSTEM. BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION. 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
    303174 VITROS DT60 II CHEMISTRY SYSTEM CHEMISTRY ANALYZER JJE ORTHO-CLINICAL DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1