BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS 5600 INTEGRATED SYSTEM

    MDR report key: 12318968 · Received August 13, 2021

    Report

    Report Number
    1319681-2021-00066
    Event Type
    Malfunction
    Date Received
    August 13, 2021
    Date of Event
    July 21, 2021
    Report Date
    August 13, 2021
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION DETERMINED THAT A HIGHER THAN EXPECTED VITROS AMON RESULT WAS OBTAINED WHEN PROCESSING A PRECISION TEST USING A PATIENT SAMPLE PROCESSED USING VITROS CHEMISTRY PRODUCTS AMON SLIDES LOT 1018-0255-7830 ON A VITROS 5600 INTEGRATED SYSTEM. THE ASSIGNABLE CAUSE OF THE HIGHER THAN EXPECTED VITROS AMON RESULT IS AN INSTRUMENT ISSUE RELATED TO MICROSLIDE INCUBATOR CONTAMINATION. THE CAUSE OF THE INCUBATOR CONTAMINATION IS UNKNOWN. PRIOR TO SERVICE ACTIONS PERFORMED BY AN ORTHO FIELD ENGINEER, A WITHIN-RUN VITROS AMON PRECISION TEST PERFORMED BY THE CUSTOMER USING A PATIENT SAMPLE YIELDED UNACCEPTABLE RESULTS. IN ADDITION, HISTORICAL QUALITY CONTROL RESULTS WERE IMPRECISE INDICATING THE VITROS 5600 INTEGRATED SYSTEM WAS NOT PERFORMING AS INTENDED IN COMBINATION WITH VITROS AMON. ACCEPTABLE WITHIN-RUN VITROS AMON PRECISION RESULTS WERE OBTAINED AFTER SERVICE ACTIONS INDICATING AN INSTRUMENT RELATED ISSUE IS THE LIKELY ASSIGNABLE CAUSE OF THE EVENT. SERVICE ACTIONS PERFORMED ON THE VITROS 5600 INTEGRATED SYSTEM INCLUDED CLEANING THE CM/RT RING, REPLACING THE CM/RT EVAPORATION CAPS, REPLACING THE CM DRIVE MOTOR AND BELT AND PROCESSING CORRECTION FACTORS. (B)(4)

    Description of Event or Problem · 0

    THE INVESTIGATION DETERMINED THAT A HIGHER THAN EXPECTED VITROS AMMONIA (AMON) RESULT WAS OBTAINED WHEN PROCESSING A PRECISION TEST USING A PATIENT SAMPLE PROCESSED USING VITROS CHEMISTRY PRODUCTS AMON SLIDES LOT 1018-0255-7830 ON A VITROS 5600 INTEGRATED SYSTEM. RESULT OF 93.7 UMOL/L VS AN EXPECTED RESULT OF 65.0 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 HIGHER THAN EXPECTED VITROS AMON RESULT WAS OBTAINED WHEN PROCESSING A PRECISION TEST. NO RESULTS WERE REPORTED OUT OF THE LABORATORY. THERE WAS NO REPORTED ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC (ORTHO) COMPLAINT NUMBER (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1217895 VITROS 5600 INTEGRATED SYSTEM CHEMISTRY ANALYZER JJE ORTHO-CLINICAL DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1