BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 2

    MDR report key: 1056355 · Received May 30, 2008

    Report

    Report Number
    1319808-2008-00160
    Event Type
    Malfunction
    Date Received
    May 30, 2008
    Date of Event
    May 2, 2008
    Report Date
    May 2, 2008
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    JIX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION OF THIS EVENT CONCLUDED THAT THE CUSTOMER OBTAINED ATYPICAL CALIBRATION RESPONSES THAT ARE INDICATIVE OF RECONSTITUTION ERROR. AFTER USING CALIBRATORS RECONSTITUTED IN ACCORDANCE WITHIN OCD RECOMMENDATIONS, ACCEPTABLE CALIBRATOR RESPONSES AND CALIBRATION PARAMETERS WERE OBTAINED. THE QC RESULTS OBTAINED POST-RECALIBRATION WERE ALL ACCEPTABLE. THE ROOT CAUSE OF THE EVENT WAS USER ERROR.

    Description of Event or Problem · 1

    THE CUSTOMER OBSERVED POSITIVELY BIASED K+ QC RESULTS ON A VITROS 350 ANALYZER. NO PT SAMPLES WERE PROCESSED DUE TO THE BIASED QC RESULTS. BIASED RESULTS OF THE DIRECTION AND MAGNITUDE OBSERVED MAY RESULTS IN INAPPROPRIATE PHYSICIAN ACTION. THERE WAS REPORT OF PT HARM AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 2 IN VITRO DIAGNOSTIC CALIBRATOR KIT JIX ORTHO-CLINICAL DIAGNOSTICS NA 0207

    Patients

    Seq Age Sex Outcome Treatment
    1