BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS CHEMISTRY PRODUCTS AMON REAGENT

    MDR report key: 1634967 · Received March 19, 2010

    Report

    Report Number
    1319809-2010-00005
    Event Type
    Malfunction
    Date Received
    March 19, 2010
    Date of Event
    December 23, 2009
    Report Date
    June 8, 2010
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    JID
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION INTO THIS EVENT FOUND THAT THERE IS NO EVIDENCE TO SUGGEST THAT THE VITROS 5,1 FS ANALYZER OR AMON REAGENT PACK WAS NOT PERFORMING AS EXPECTED. THE ROOT CAUSE OF THIS EVENT IS UNKNOWN; HOWEVER; THE EDTA PLASMA COLLECTION DEVICE OR PRE-ANALYTICAL SAMPLE HANDLING CANNOT BE RULED OUT AS A POTENTIAL ROOT CAUSE.

    Additional Manufacturer Narrative · 1

    FURTHER INVESTIGATION OF THIS EVENT DETERMINED THE MOST LIKELY CAUSE WAS USER ERROR. ALTHOUGH THE VITROS AMON INSTRUCTIONS FOR USE (IFU) STATES EDTA PLASMA IS AN ACCEPTABLE SAMPLE TYPE, THE SPECIFIC EDTA PLASMA COLLECTION DEVICE MANUFACTURER'S LABELING DOES NOT RECOMMEND THAT THE DEVICE BE USED FOR AMMONIA TESTING.

    Description of Event or Problem · 1

    THE CUSTOMER OBSERVED POSITIVELY BIASED AMMONIA RESULTS FOR ONE PATIENT SAMPLE PROCESSED ON THE VITROS 5,1 FS CHEMISTRY SYSTEM. BIASED RESULTS OF THE DIRECTION AND MAGNITUDE OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION. ERRONEOUS AMON PATIENT SAMPLE RESULTS WERE NOT REPORTED OUTSIDE OF THE LABORATORY. THERE WAS NO REPORT OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC. (B)(4)

    Description of Event or Problem · 1

    (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITROS CHEMISTRY PRODUCTS AMON REAGENT IN-VITRO DIAGNOSTIC JID ORTHO-CLINICAL DIAGNOSTICS 1011-0219-0877

    Patients

    Seq Age Sex Outcome Treatment
    1