BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS 5600 INTEGRATED SYSTEM

    MDR report key: 10648677 · Received October 8, 2020

    Report

    Report Number
    1319681-2020-00094
    Event Type
    Malfunction
    Date Received
    October 8, 2020
    Date of Event
    September 9, 2020
    Report Date
    October 8, 2020
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION CONCLUDED THAT A LOWER THAN EXPECTED RESULT WAS OBTAINED FROM A SINGLE LEVEL OF A NON-VITROS BIORAD LOT 54320 L3 CONTROL FLUID, USING VITROS AMON MICRO SLIDES ON A VITROS 5600 INTEGRATED SYSTEM. THE INVESTIGATION CONCLUDED THE MOST LIKELY ASSIGNABLE CAUSE IS INSTRUMENT RELATED ASSOCIATED WITH MICROSLIDE INCUBATOR CONTAMINATION. THE CUSTOMER REPLACED THE MICROSLIDE INCUBATOR EVAPORATION CAPS. AFTER REPLACING THE MICROSLIDE EVAPORATION CAPS, ACCEPTABLE VITROS AMON PERFORMANCE WAS OBTAINED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTIONS CENTER (TSC) TO REPORT AN UNEXPECTED RESULT OBTAINED FROM A SINGLE LEVEL OF NON-VITROS BIORAD AMMONIA/ ETHANOL CONTROL, LOT 54320, USING VITROS CLINICAL CHEMISTRY PRODUCTS AMMONIA (AMON) SLIDES ON A VITROS 5600 INTEGRATED SYSTEM. BIORAD L3 AMON RESULT OF 172.6 UMOL/L VS. THE EXPECTED RESULT OF 224.0 UMOL/L. BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED ON PATIENT SAMPLES. THE AFFECTED FLUID WAS A NON-PATIENT SAMPLE. THERE WAS NO REPORT OF AFFECTED PATIENT RESULTS AND THERE WAS NO ALLEGATION OF PATIENT HARM. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC. COMPLAINT NUMBER (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1118343 VITROS 5600 INTEGRATED SYSTEM CHEMISTRY ANALYZER JJE ORTHO-CLINICAL DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1