BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BRAND NAME: VITROS 5600 INTEGRATED SYSTEM

    MDR report key: 10896462 · Received November 24, 2020

    Report

    Report Number
    1319681-2020-00118
    Event Type
    Malfunction
    Date Received
    November 24, 2020
    Date of Event
    October 24, 2020
    Report Date
    November 24, 2020
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT LOWER THAN EXPECTED VITROS DGXN RESULTS WERE OBTAINED FROM A SINGLE LEVEL OF NON-VITROS BIORAD CONTROL, LOT: 45860 AND A SINGLE LEVEL OF VITROS PV II LOT: T7911 USING VITROS DGXN SLIDE LOT 1920-0258-2396, TESTED ON A VITROS 5600 SYSTEM. BIORAD L3 DGXN RESULT OF 1.96 NG/ML VS. AN EXPECTED RESULT OF 2.46 NG/ML. THE MOST LIKELY ASSIGNABLE CAUSE IS AN INSTRUMENT RELATED ISSUE. THE SAME QUALITY CONTROL FLUIDS WERE GENERATING RESULTS WITHIN THE EXPECTED RANGES ON AN ALTERNATE VITROS 5600 SYSTEM ON SITE. AN ORTHO FIELD ENGINEER WENT ON SITE ON MULTIPLE OCCASIONS AND PERFORMED MULTIPLE SERVICE ACTIONS TO THE VITROS 5600 SYSTEM, WHICH INCLUDED DISCOVERING A SMALL TEAR IN THE IWF TUBING. THE FE REPLACED THE IWF TUBING AND PUMP AND THE CM/RT INCUBATOR DRIVE MOTOR BELT, LEAK PAD, IWF Z DRIVE MOTOR, AND THE SLIDE INPUT BLADE #2. THE FE CLEANED THE TIP LOCATOR, AND PERFORMED ADJUSTMENTS TO THE DISPENSE BLADE AND THE IWF SUBSYSTEM. ACCEPTABLE VITROS DGXN PERFORMANCE WAS OBTAINED AFTER THESE SERVICE ACTIONS WERE PERFORMED. (B)(6).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT LOWER THAN EXPECTED VITROS DGXN RESULTS WERE OBTAINED FROM A SINGLE LEVEL OF NON-VITROS BIORAD CONTROL, LOT 45860 AND A SINGLE LEVEL OF VITROS PV II LOT T7911 USING VITROS DGXN SLIDE LOT: 1920-0258-2396, TESTED ON A VITROS 5600 SYSTEM. BIORAD L3 DGXN RESULT OF 1.96 NG/ML VS. AN EXPECTED RESULT OF 2.46 NG/ML. VITROS PV II DGXN RESULTS OF 1.92 AND 1.90 NG/ML VS. AN EXPECTED RESULT OF 2.51 NG/ML. BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED. THE AFFECTED QUALITY CONTROL SAMPLE WAS A NON-PATIENT SAMPLE. THE CUSTOMER MADE NO INDICATION THAT PATIENT SAMPLE RESULTS WERE AFFECTED. THERE WERE NO REPORTED ALLEGATIONS OF PATIENT HARM. THIS REPORT IS NUMBER 1 OF 3 MDR¿S FOR THIS EVENT. THREE (3) 3500A FORMS ARE BEING SUBMITTED FOR THIS EVENT AS 3 DEVICES WERE INVOLVED. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC. COMPLAINT NUMBER (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1354666 BRAND NAME: VITROS 5600 INTEGRATED SYSTEM IMMUNODIAGNOSTIC SYSTEMS JJE ORTHO-CLINICAL DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1