BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS 5600 INTEGRATED SYSTEM

    MDR report key: 3083392 · Received April 29, 2013

    Report

    Report Number
    1319681-2013-00094
    Event Type
    Malfunction
    Date Received
    April 29, 2013
    Date of Event
    March 23, 2013
    Report Date
    April 29, 2013
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT MULTIPLE, NON-REPRODUCIBLE, HIGHER THAN EXPECTED; VITROS AMON QUALITY CONTROL RESULTS WERE OBTAINED ON A VITROS 5600 INTEGRATED SYSTEM. THE CUSTOMER WAS USING NEW CLEANING WIPES CONTAINING AMMONIA. THE VITROS 5600 INTEGRATED SYSTEM REFERENCE GUIDE STATES "NEVER USE AMMONIA CLEANERS ON OR NEAR THE SYSTEM. DO NOT USE SOLVENTS, ALCOHOL, AMMONIA, GLASS CLEANERS, OR CLEANING AGENTS CONTAINING ABRASIVES TO CLEAN THE INCUBATOR EVAPORATION CAPS. THESE ITEMS WILL DAMAGE THE CAPS AND AFFECT SYSTEM PERFORMANCE." AN OCD FIELD ENGINEER CLEANED THE MICROSLIDE INCUBATOR AND REPLACED THE INCUBATOR EVAPORATION CAPS TO RETURN THE SYSTEM TO EXPECTED PERFORMANCE. THE ROOT CAUSE OF THE EVENT IS USER ERROR. THERE WAS NO EVIDENCE THAT AN INSTRUMENT OR REAGENT RELATED ISSUE CONTRIBUTED TO THE EVENT.

    Description of Event or Problem · 1

    THE CUSTOMER OBTAINED MULTIPLE, NON-REPRODUCIBLE, HIGHER THAN EXPECTED, VITROS AMON QUALITY CONTROL RESULTS (QC FLUID BIORAD 2 = 97.85, 98.89 VS. EXPECTED RESULT= 72.8 MOL/L) ON A VITROS 5600 INTEGRATED SYSTEM. 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 RUN DURING THE TIME FRAME OF THE EVENT. THERE WAS NO REPORT OF PATIENT HARM AS A RESULT OF THIS EVENT. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185594 VITROS 5600 INTEGRATED SYSTEM CHEMISTRY ANALYZER JJE ORTHO-CLINICAL DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1