BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS CHEMISTRY PRODUCTS AMON REAGENT

    MDR report key: 2521736 · Received April 6, 2012

    Report

    Report Number
    1319809-2012-00032
    Event Type
    Malfunction
    Date Received
    April 6, 2012
    Date of Event
    March 2, 2012
    Report Date
    April 6, 2012
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    JID
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN ALLEGED LOWER THAN EXPECTED VITROS AMON PATIENT RESULT WAS OBTAINED ON A VITROS 5,1 FS CHEMISTRY SYSTEM. THE INVESTIGATION TO DATE HAS BEEN UNABLE TO CONFIRM THE EVENTS REPORTED BY THE CUSTOMER CONTACT. LIMITED INFORMATION HAS BEEN PROVIDED REGARDING THIS EVENT; THEREFORE A LIKELY ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME. ADDITIONALLY, A PRODUCT MANUFACTURE DATE AND EXPIRY DATE CANNOT BE PROVIDED AS THE PRODUCT LOT NUMBER WAS NOT PROVIDED TO OCD WHEN REQUESTED. THE ROOT CAUSE OF THIS EVENT IS UNKNOWN, AND THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 1

    A CUSTOMER ALLEGEDLY OBTAINED A FALSE LOW VITROS AMON RESULT FROM A PATIENT SAMPLE USING THE VITROS 5,1 FS CHEMISTRY SYSTEM. IT WAS ALLEGED A VITROS AMON RESULT OF 7.0 UMOL/L, VS. AN EXPECTED RESULT OF 100 UMOL/L, WAS OBTAINED AND REPORTED FROM THE LABORATORY. IT IS UNKNOWN IF ANY MEDICAL ACTION WAS TAKEN IN RESPONSE TO THE FALSE LOW VITROS AMON RESULT AS THIS INFORMATION WAS NOT PROVIDED WHEN REQUESTED. HOWEVER, A BIASED RESULT OF THE DIRECTION AND MAGNITUDE OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF UNDETECTED. THERE WAS NO ALLEGATION PATIENT HARM. (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

    Patients

    Seq Age Sex Outcome Treatment
    1