BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS 250 CHEMISTRY SYSTEM

    MDR report key: 1045186 · Received May 9, 2008

    Report

    Report Number
    1319681-2008-00132
    Event Type
    Malfunction
    Date Received
    May 9, 2008
    Date of Event
    April 10, 2008
    Report Date
    April 10, 2008
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS, INC.
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION INTO THIS EVENT DETERMINED THAT A RANDOM K+ OUTLIER OCCURRED DURING A K+ PRECISION TEST. THERE IS NO INDICATION TO SUGGEST THAT THE REAGENT OR ANALYZER MALFUNCTIONED. THE INVESTIGATION DID NOT DETERMINE THE ROOT CAUSE OF THE SINGLE BIASED RESULT. THE ROOT CAUSE OF THE EVENT IS UNK.

    Description of Event or Problem · 1

    A CUSTOMER OBSERVED POSITIVELY BIASED K+ QC RESULTS ON THE VITROS 250 ANALYZER. BIASED RESULTS OF THE DIRECTION AND MAGNITUDE OBSERVED MAY 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 250 CHEMISTRY SYSTEM CLINICAL CHEMISTRY ANALYZER JJE ORTHO-CLINICAL DIAGNOSTICS, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1