BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITROS 5600 INTEGRATED SYSTEM

    MDR report key: 1419249 · Received July 22, 2009

    Report

    Report Number
    1319681-2009-00212
    Event Type
    Injury
    Date Received
    July 22, 2009
    Date of Event
    June 24, 2009
    Report Date
    June 25, 2009
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    NBC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION INTO THIS EVENT DETERMINED THAT AN ELEVATED VITROS NT-PROBNP RESULT WAS OBTAINED FROM A SINGLE PT PLASMA SAMPLE AND REPORTED BY THE LABORATORY. IT WAS REPORTED THAT THE PT EXPERIENCED RENAL FAILURE AS A RESULT OF FLUID RESTRICTION ORDERED BY THE PHYSICIAN DUE TO THE ELEVATED VITROS NT-PROBNP RESULT. THE INVESTIGATION WAS UNABLE TO DETERMINE IF THE REPORTED RESULT WAS INCORRECT. NO SPECIFIC VITROS 5600 ANALYZER MALFUNCTION OR VITROS NT-PROBNP PRODUCT ISSUE COULD BE IDENTIFIED AS THE CUSTOMER DID NOT PROVIDE ADDITIONAL INFO REQUESTED FOR THE INVESTIGATION. THE ROOT CAUSE OF THIS EVENT IS UNKNOWN.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT A PHYSICIAN ORDERED FLUID RESTRICTION BASED ON AN ELEVATED VITROS NT-PROBNP RESULT OBTAINED ON A VITROS 5600 INTEGRATED SYSTEM. BIASED RESULTS OF THE DIRECTION AND MAGNITUDE OBSERVED COULD LEAD TO INAPPROPRIATE PHYSICIAN ACTION. THE PHYSICIAN INDICATED THAT THE PT EXPERIENCED RENAL FAILURE, HOWEVER, IT IS UNKNOWN IF THERE WAS ACTUAL PT HARM AS A RESULT OF THIS EVENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITROS 5600 INTEGRATED SYSTEM CHEMISTRY ANALYZER NBC ORTHO-CLINICAL DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1