BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS DT60 SYSTEM

    MDR report key: 910283 · Received September 11, 2007

    Report

    Report Number
    1319681-2007-00270
    Event Type
    Malfunction
    Date Received
    September 11, 2007
    Date of Event
    August 17, 2007
    Report Date
    August 17, 2007
    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

    INVESTIGATION INTO THIS EVENT DETERMINED THAT THE CALIBRATION PARAMETERS AND RESPONSES WERE NOT AS EXPECTED. ADDITIONAL TROUBLESHOOTING WAS NOT PERFORMED AT THE CUSTOMER SITE. THE ANALYZER HAS BEEN RETURNED TO THE DEPOT FOR SERVICE. THE ROOT CAUSE OF THE EVENT HAS NOT BEEN DETERMINED.

    Description of Event or Problem · 1

    A CUSTOMER OBSERVED NEGATIVELY BIASED K+ QC RESULTS ON THE DT60 ANALYZER. BIASED RESULTS OF THE DIRECTION AN MAGNITUDE OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION. THERE WAS NO REPORT OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 YR