BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS 5600 INTEGRATED SYSTEM

    MDR report key: 3950001 · Received July 22, 2014

    Report

    Report Number
    1319681-2014-00125
    Event Type
    Malfunction
    Date Received
    July 22, 2014
    Date of Event
    June 29, 2014
    Report Date
    July 22, 2014
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT MULTIPLE LOWER THAN EXPECTED VITROS GENT QUALITY CONTROL RESULTS WERE OBTAINED ON A VITROS 5600 INTEGRATED SYSTEM. THERE WAS NO INDICATION THAT A REAGENT ISSUE CONTRIBUTED TO THE EVENT. THE DEFINITIVE CAUSE OF THE EVENT IS MOST LIKELY INSTRUMENT RELATED. A VITROS GENT WITHIN-RUN PRECISION TEST WAS OUTSIDE OF ACCEPTABLE GUIDELINES. AN OCD FIELD ENGINEER PERFORMED SERVICE ACTIONS TO THE VITROS 5600 INSTRUMENT AND FOLLOWING THESE SERVICE ACTIONS, ACCEPTABLE GENT PERFORMANCE WAS OBTAINED.

    Description of Event or Problem · 1

    THE CUSTOMER OBTAINED LOWER THAN EXPECTED VITROS GENT QUALITY CONTROL RESULTS ON MULTIPLE QUALITY CONTROL FLUIDS (QC FLUID B2957= 4.24 VS. EXPECTED 7.16 UG/ML; QC FLUID BIORAD 1= 1.35, 1.08 VS. EXPECTED 2.89 UG/ML; QC FLUID BIORAD 2= 1.64, 2.50, 2.43 VS. EXPECTED 5.44 UG/ML; QC FLUID BIORAD 3= 3.67 VS. EXPECTED 8.31 UG/ML) USING A VITROS 5600 INTEGRATED SYSTEM. BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF PATIENT SAMPLES WERE AFFECTED. THERE WAS NO REPORT OF AFFECTED PATIENT RESULTS AND THERE WAS NO ALLEGATION OF PATIENT HARM. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    428031 VITROS 5600 INTEGRATED SYSTEM CHEMISTRY SYSTEM JJE ORTHO-CLINICAL DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1