BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS DT60 CHEMISTRY SYSTEM

    MDR report key: 814169 · Received November 16, 2004

    Report

    Report Number
    1319681-2004-00298
    Event Type
    Malfunction
    Date Received
    November 16, 2004
    Date of Event
    October 18, 2004
    Report Date
    October 18, 2004
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: INVESTIGATION INTO THIS EVENT FOUND THAT THE EQUIPMENT WAS PERFORMING AS EXPECTED. THE CUSTOMER CLEANED THE DTE PIPETTE, OPENED A NEW VIAL OF ELECTROLYTE REFERENCE FLUID AND RAN A FRESH SET OF CONTROL FLUIDS RESULTING IN ACCEPTABLE QC RESULTS. THE ROOT CAUSE OF THE BIASED K+ QC RESULTS IS UNK.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED NEGATIVELY BIASED QUALITY CONTROL (QC) RESULTS FOR K+ ON THEIR VITROS DT60 SYSTEM. NEGATIVELY BIASED K+ RESULTS COULD LEAD TO INAPPROPRIATE PHYSICIAN ACTION. THERE WAS NO REPORT OF PT HARM AS A RESULT OF THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NA