BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS DT60 II CHEMISTRY SYSTEM

    MDR report key: 1897467 · Received November 12, 2010

    Report

    Report Number
    1319681-2010-00249
    Event Type
    Malfunction
    Date Received
    November 12, 2010
    Date of Event
    September 29, 2010
    Report Date
    November 12, 2010
    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 LOWER THAN EXPECTED VITROS NA+ DT AND VITROS K+ DT RESULTS WERE OBTAINED FROM PATIENT AND CONTROL FLUID SAMPLES PROCESSED ON THE VITROS DT60 II CHEMISTRY SYSTEM. OCD SERVICE REPLACED THE SLIDE GUIDES TO RETURN THE INSTRUMENT TO EXPECTED OPERATION.A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED, HOWEVER THE EVENT IS MOST LIKELY INSTRUMENT RELATED.

    Description of Event or Problem · 1

    THE CUSTOMER OBTAINED LOWER THAN EXPECTED VITROS NA+ DT AND VITROS K+ DT RESULTS FROM PATIENT AND CONTROL FLUID SAMPLES PROCESSED ON THE VITROS DT60 II CHEMISTRY SYSTEM. BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION. THE LOWER THAN EXPECTED VITROS NA+ DT AND VITROS K+ DT VALUES WERE INITIALLY REPORTED TO THE CLINICIAN, AND AS A RESULT THE PATIENT MAY HAVE BEEN ADMINISTERED AN ELECTROLYTE SUPPLEMENT. CORRECTED REPORTS WERE ISSUED. THERE WAS NO REPORT OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC. (B)(4)

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1