BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS DT60 SYSTEM

    MDR report key: 689001 · Received March 14, 2006

    Report

    Report Number
    1319681-2006-00045
    Event Type
    Malfunction
    Date Received
    March 14, 2006
    Date of Event
    February 14, 2006
    Report Date
    February 14, 2006
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER OBSERVED BIASED K+ QC RESULTS ON THE VITROS DT60 ANALYZER. BIASED RESULTS OF THE DIRECTION AND MAGNITUDE OBSERVED COULD LEAD TO INAPPROPRIATE PHYSICIAN ACTION. BIASED RESULTS WERE REPORTED AND QUESTIONED BY THE PHYSICIAN. THERE WAS NO REPORT OF PATIENT HARM AS A RESULT OF THIS EVENT.

    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 NA