BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS 5600 INTEGRATED SYSTEM

    MDR report key: 5989983 · Received September 30, 2016

    Report

    Report Number
    1319681-2016-00215
    Event Type
    Malfunction
    Date Received
    September 30, 2016
    Date of Event
    September 6, 2016
    Report Date
    September 30, 2016
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT A LOWER THAN EXPECTED VITROS DGXN QUALITY CONTROL RESULT WAS OBTAINED FROM A SINGLE LEVEL OF BIORAD QUALITY CONTROL FLUID USING VITROS DGXN REAGENT, TESTED ON A VITROS 5600 INTEGRATED SYSTEM. THE MOST LIKELY ASSIGNABLE CAUSE IS INSTRUMENT RELATED CAUSED BY CRIMPED IMMUNO WASH FLUID (IWF) TUBING THAT PREVENTED IWF FROM BEING DISPENSED. THE CUSTOMER RE-ALIGNED THE IWF TUBING AND GENERATED ACCEPTABLE QUALITY CONTROL RESULTS INDICATING RE-ALIGNING THE IWF TUBING HAD RESOLVED THE ISSUE. THE MOST LIKELY ASSIGNABLE CAUSE OF THIS EVENT WAS CONCLUDED TO BE AN INSTRUMENT ISSUE.

    Description of Event or Problem · 1

    A CUSTOMER OBSERVED LOWER THAN EXPECTED VITROS DGXN QUALITY CONTROL RESULTS OBTAINED FROM A NON-VITROS BIORAD CONTROL FLUID WHEN USING A VITROS 5600 INTEGRATED SYSTEM. BIORAD L2 = <0.4 VERSUS EXPECTED 2.51 NG/ML. BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF PATIENT SAMPLES WERE AFFECTED. ORTHO CLINICAL DIAGNOSTICS (ORTHO) HAS NOT BEEN MADE AWARE OF ANY ERRONEOUS VITROS DGXN PATIENT SAMPLE RESULTS OBTAINED OR REPORTED FROM THE LABORATORY DURING THE TIME FRAME OF THIS EVENT, HOWEVER, THE INVESTIGATION COULD NOT RULE OUT THAT PATIENT SAMPLES WERE NOT, OR WOULD NOT BE AFFECTED IF THE EVENT WERE TO RECUR UNDETECTED. THERE WAS NO ALLEGATION OF ACTUAL PATIENT HARM AS A RESULT OF THIS EVENT. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    641199 VITROS 5600 INTEGRATED SYSTEM CHEMISTRY ANALYZER JJE ORTHO-CLINICAL DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1