BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VTROS 5600 INTEGRATED SYSTEM

    MDR report key: 10145674 · Received June 11, 2020

    Report

    Report Number
    1319681-2020-00033
    Event Type
    Malfunction
    Date Received
    June 11, 2020
    Date of Event
    March 25, 2020
    Report Date
    June 11, 2020
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT LOWER THAN EXPECTED VITROS AMON RESULTS WERE OBTAINED FROM A VITROS LIQUID PERFORMANCE VERIFIER CONTROL USING VITROS AMON REAGENT ON A VITROS 5600 INTEGRATED CHEMISTRY SYSTEM. THE MOST LIKELY ASSIGNABLE CAUSE OF THE HIGHER THAN EXPECTED VITROS AMON QUALITY CONTROL RESULTS IS AN INSTRUMENT EVENT RELATED TO MICRO SLIDE INCUBATOR CONTAMINATION. HISTORICAL VITROS AMON QUALITY CONTROL RESULTS INDICATE ACCEPTABLE ACCURACY; HOWEVER, A WITHIN-RUN AMON PRECISION TEST WAS OUTSIDE OF ORTHO GUIDELINES INDICATING THE VITROS 5600 INTEGRATED SYSTEM WAS NOT PERFORMING AS INTENDED.

    Description of Event or Problem · 1

    AN ORTHO CLINICAL DIAGNOSTICS (ORTHO) LABORATORY SPECIALIST (LS) CONTACTED ORTHO CLINICAL DIAGNOSTICS (ORTHO) GLOBAL TECHNICAL SUPPORT CENTER (TSC) ON BEHALF OF A CUSTOMER. THE CUSTOMER HAS BEEN OBSERVING IMPRECISE AMON RESULTS OBTAINED WHEN PROCESSING QUALITY CONTROL FLUIDS ON A VITROS 5600 INTEGRATED CHEMISTRY SYSTEM. VITROS LIQUID PERFORMANCE VERIFIER II, LOT J6667. VITROS AMON RESULTS 143.1*, 136.0*, 132.7* UMOL/L VERSUS EXPECTED VITROS AMON RESULT 182 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 CUSTOMER OBTAINED THE LOWER THAN EXPECTED RESULTS WHEN PROCESSING QUALITY CONTROL FLUIDS. ORTHO WAS NOT MADE AWARE OF ANY ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    610007 VTROS 5600 INTEGRATED SYSTEM CHEMISTRY ANALYZER JJE ORTHO-CLINICAL DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1