BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS CHEMISTRY PRODUCTS AMON SLIDES

    MDR report key: 5019464 · Received August 20, 2015

    Report

    Report Number
    1319809-2015-00101
    Event Type
    Malfunction
    Date Received
    August 20, 2015
    Date of Event
    July 28, 2015
    Report Date
    August 20, 2015
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    JID
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT AN UNEXPECTED, NONREPRODUCIBLE VITROS AMON RESULT WAS OBTAINED FROM A SINGLE PATIENT SAMPLE PROCESSED USING VITROS AMON SLIDES ON A VITROS 250 CHEMISTRY SYSTEM. THE ASSIGNABLE CAUSE FOR THE EVENT COULD NOT BE DETERMINED WITH THE INFORMATION AVAILABLE, HOWEVER THE POSSIBILITY THAT AN UNEXPECTED VITROS AMON REAGENT PERFORMANCE, PRE-ANALYTICAL HANDLING ISSUE OR AN UNEXPECTED VITROS 250 SYSTEM ISSUE HAD CONTRIBUTED TO THE RESULT COULD NOT BE RULED OUT.

    Description of Event or Problem · 1

    THE CUSTOMER COMPLAINED THAT AN UNEXPECTED, NONREPRODUCIBLE VITROS AMON RESULT WAS OBTAINED FROM A SINGLE PATIENT SAMPLE PROCESSED USING VITROS AMON SLIDES ON A VITROS 250 CHEMISTRY SYSTEM. VITROS AMON RESULT: 132 VS EXPECTED 88 UMOL/L. BIASED RESULTS OF THE DIRECTION AND MAGNITUDE OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION. THE TECHNICAL SOLUTION CENTER WAS UNABLE TO DETERMINE WHAT AMON RESULT, IF ANY, WAS REPORTED OUT OF THE LABORATORY FOR THE AFFECTED PATIENT. THERE WAS NO ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC. COMPLAINT NUMBER (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    551611 VITROS CHEMISTRY PRODUCTS AMON SLIDES IN-VITRO DIAGNOSTIC JID ORTHO-CLINICAL DIAGNOSTICS 1015-0238-7392

    Patients

    Seq Age Sex Outcome Treatment
    1