BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS CHEMISTRY PRODUCTS AMON SLIDES

    MDR report key: 12656072 · Received October 19, 2021

    Report

    Report Number
    1319809-2021-00150
    Event Type
    Malfunction
    Date Received
    October 19, 2021
    Date of Event
    September 16, 2021
    Report Date
    October 19, 2021
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    JID
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION DETERMINED THAT A HIGHER THAN EXPECTED VITROS AMMONIA (AMON) RESULT WAS OBTAINED FROM A PATIENT SAMPLE AND THAT LOWER THAN EXPECTED RESULTS WERE OBTAINED FROM A QUALITY CONTROL FLUID USING VITROS CHEMISTRY PRODUCTS AMON SLIDES ON A VITROS 350 CHEMISTRY SYSTEM. THE ASSIGNABLE CAUSE OF THE UNEXPECTED, IMPRECISE VITROS AMON RESULTS COULD NOT BE DETERMINED, HOWEVER, AN INSTRUMENT ISSUE RELATED TO INCUBATOR CONTAMINATION IN COMBINATION WITH A MECHANICAL ISSUE CANNOT BE RULED OUT. PRIOR TO SERVICE ACTIONS PERFORMED BY AN ORTHO FIELD ENGINEER, THE CUSTOMER OBSERVED IMPRECISION USING TWO DIFFERENT VITROS AMON REAGENT LOTS, HOWEVER A WITHIN-RUN VITROS AMON PRECISION TEST PERFORMED BY THE CUSTOMER PRODUCED ACCEPTABLE RESULTS. THE CUSTOMER CONTINUED TO OBSERVE IMPRECISION ON THEIR L2 QUALITY CONTROL FLUID ACROSS TWO LOTS OF VITROS AMON, INDICATING THE VITROS 350 CHEMISTRY SYSTEM WAS NOT PERFORMING AS INTENDED IN COMBINATION WITH VITROS AMON. THE ORTHO FIELD ENGINEER PERFORMED SERVICE ACTIONS ON THE VITROS 350 CHEMISTRY SYSTEM WHICH INCLUDED CLEANING THE MICROSLIDE INCUBATOR TO REMOVE INCUBATOR CONTAMINATION, REPLACING THE EVAPORATION CAPS, CLEANING THE SAMPLE METERING PROBOSCIS, AND PERFORMING MICROSLIDE INCUBATOR ADJUSTMENTS. THE ORTHO FIELD ENGINEER INDICATED THAT THE VITROS 350 CHEMISTRY SYSTEM WAS PERFORMING AS EXPECTED FOLLOWING THE SERVICE ACTIONS, AND THE CUSTOMER REPORTED NO ADDITIONAL ISSUES WITH THEIR VITROS AMON. HOWEVER, NO POST SERVICE QC DATA OR PRECISION WAS PROVIDED, THEREFORE IT CAN'T BE CONFIRMED THAT THE SERVICE ACTIONS BY THE ORTHO FE RETURNED THE VITROS 350 SYSTEM TO ACCEPTABLE PERFORMANCE. CONTINUAL TRACKING AND TRENDING DOES NOT INDICATE A SYSTEMIC ISSUE WITH VITROS AMON LOT 1018-0255-7830. (B)(4).

    Description of Event or Problem · 0

    THE INVESTIGATION DETERMINED THAT A LOWER THAN EXPECTED VITROS AMMONIA (AMON) RESULT WAS OBTAINED FROM A QUALITY CONTROL FLUID USING VITROS CHEMISTRY PRODUCTS AMON SLIDES ON A VITROS 350 CHEMISTRY SYSTEM. VITROS LPV LEVEL 2 RESULTS OF 118.4 AND 139.3 UMOL/L VERSUS THE EXPECTED RESULT OF 174.8 UMOL/L BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED. THE HIGHER THAN EXPECTED VITROS AMON RESULT WAS OBTAINED FROM A PATIENT SAMPLE AND THE LOWER THAN EXPECTED RESULTS WERE OBTAINED FROM A NON-PATIENT QUALITY CONTROL FLUID. THERE WAS NO REPORTED ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT IS NUMBER ONE OF TWO MDR¿S FOR THIS EVENT. TWO 3500A FORMS ARE BEING SUBMITTED FOR THIS EVENT AS TWO DEVICES WERE INVOLVED. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC (ORTHO) COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1552087 VITROS CHEMISTRY PRODUCTS AMON SLIDES IN-VITRO DIAGNOSTICS JID ORTHO-CLINICAL DIAGNOSTICS 1018-0255-7830

    Patients

    Seq Age Sex Outcome Treatment
    1