BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS CHEMISTRY PRODUCTS AMON SLIDES

    MDR report key: 2042988 · Received April 7, 2011

    Report

    Report Number
    1319809-2011-00005
    Event Type
    Malfunction
    Date Received
    April 7, 2011
    Date of Event
    March 9, 2011
    Report Date
    April 7, 2011
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    JID
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT HIGHER THAN EXPECTED VITROS AMON QUALITY CONTROL RESULTS WERE OBTAINED ON A VITROS 5,1 FS CHEMISTRY SYSTEM. THE MOST LIKELY CAUSE OF THE EVENT IS USER ERROR DUE TO IMPROPER HANDLING OF VITROS AMON SLIDE CARTRIDGES. NO INSTRUMENT SERVICE WAS REQUIRED. ACCEPTABLE VITROS AMON QUALITY CONTROL PERFORMANCE WAS OBSERVED USING AN ALTERNATE SLIDE CARTRIDGE.

    Description of Event or Problem · 1

    THE CUSTOMER OBTAINED HIGHER THAN EXPECTED VITROS AMON QUALITY CONTROL RESULTS ON A VITROS 5,1 FS CHEMISTRY SYSTEM. BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF PATIENT SAMPLES WERE AFFECTED. PATIENT SAMPLES WERE NOT TESTED DURING THE TIME FRAME THAT THE HIGHER THAN EXPECTED QUALITY CONTROL RESULTS WERE OBTAINED. THERE WAS NO ALLEGATION 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 1013-0224-0312

    Patients

    Seq Age Sex Outcome Treatment
    1