BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS 5600 INTEGRATED SYSTEM

    MDR report key: 4102820 · Received September 19, 2014

    Report

    Report Number
    1319681-2014-00148
    Event Type
    Malfunction
    Date Received
    September 19, 2014
    Date of Event
    August 21, 2014
    Report Date
    September 19, 2014
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT LOWER THAN EXPECTED VITROS CRBM AND PHYT QUALITY CONTROL RESULTS WERE OBTAINED ON A VITROS 5600 INTEGRATED SYSTEM. THE INVESTIGATION DETERMINED THE ASSIGNABLE CAUSE WAS USER ERROR IN INSTALLING THE IMMUNORATE WASH FLUID (IWF) TUBING IN THE INCORRECT ORIENTATION. AFTER THE IWF TUBING WAS RE-INSTALLED IN THE PROPER ORIENTATION, ACCEPTABLE CRBM AND PHYT QUALITY CONTROL RESULTS WERE OBTAINED. THE VITROS 5600 INTEGRATED SYSTEM DID NOT MALFUNCTION.

    Description of Event or Problem · 1

    THE CUSTOMER OBTAINED LOWER THAN EXPECTED VITROS CRBM AND PHYT RESULTS USING VITROS AND NON-OCD QUALITY CONTROL FLUIDS ON A VITROS 5600 INTEGRATED SYSTEM. CRBM: BIORAD L2= 6.1 UG/ML VS. EXPECTED 7.64 UG/ML; BIORAD L3= 8.2 UG/ML VS. EXPECTED 10.70 UG/ML; TDM L1= 3.5 UG/ML VS. EXPECTED 4.68 UG/ML; TDM L3= 8.5 UG/ML VS. EXPECTED 13.19 UG/ML. PHYT: BIORAD L2= 8.2 UG/ML VS. EXPECTED 14.6 UG/ML; BIORAD L3= 7.6 UG/ML VS. EXPECTED 26.4 UG/ML; TDM L1= 4.5 UG/ML VS. EXPECTED 8.0 UG/ML; TDM L3= 9.9 UG/ML VS. EXPECTED 28.0 UG/ML. BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED ON PATIENT SAMPLES. NO PATIENT SAMPLES WERE KNOWN TO HAVE BEEN AFFECTED OR REPORTED FROM THE LABORATORY. THERE WAS NO ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    584394 VITROS 5600 INTEGRATED SYSTEM CHEMISTRY SYSTEM JJE ORTHO-CLINICAL DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1