BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS CHEMISTRY PRODUCTS AMON SLIDES

    MDR report key: 1622480 · Received March 4, 2010

    Report

    Report Number
    1319809-2010-00002
    Event Type
    Malfunction
    Date Received
    March 4, 2010
    Date of Event
    February 4, 2010
    Report Date
    March 4, 2010
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    JID
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED POSITIVELY BIASED AMMONIA RESULTS WERE OBTAINED FROM PATIENT SAMPLES USING VITROS AMON SLIDES ON A VITROS 250 CHEMISTRY SYSTEM. THE PATIENT SAMPLES HAD BEEN STORED AT ROOM TEMPERATURE FOR APPROXIMATELY 1 HOUR PRIOR TO TESTING ON THE VITROS 250 CHEMISTRY SYSTEM. THE INSTRUCTIONS FOR USE FOR VITROS AMON SLIDES INDICATES: "MIX SAMPLES BY GENTLE INVERSION AND BRING TO ROOM TEMPERATURE, 18-28 DEGREES C (64-82 DEGREES F); ANALYZE IMMEDIATELY" AND ALSO INDICATES ROOM TEMPERATURE STORAGE OF SAMPLES IS NOT RECOMMENDED. THE ROOT CAUSE OF THIS EVENT IS USER ERROR RELATED TO PRE-ANALYTICAL SAMPLE HANDLING.

    Description of Event or Problem · 1

    POSITIVELY BIASED PATIENT RESULTS USING VITROS AMON SLIDES ON A VITROS 250 CHEMISTRY SYSTEM WERE OBSERVED WHEN PERFORMING A PATIENT CORRELATION STUDY. BIASED RESULTS OF THE DIRECTION AND MAGNITUDE OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION. NO PATIENT RESULTS WERE REPORTED. THERE WAS NO REPORT OF PATIENT HARM AS A RESULT OF THIS EVENT. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITROS CHEMISTRY PRODUCTS AMON SLIDES IN VITRO DIAGNOSTIC JID ORTHO-CLINICAL DIAGNOSTICS 1011-0219-2405

    Patients

    Seq Age Sex Outcome Treatment
    1