BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS CHEMISTRY PRODUCTS AMON SLIDES

    MDR report key: 11812991 · Received May 12, 2021

    Report

    Report Number
    1319809-2021-00081
    Event Type
    Malfunction
    Date Received
    May 12, 2021
    Date of Event
    April 12, 2021
    Report Date
    May 12, 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 · 1

    THE INVESTIGATION DETERMINED THAT HIGHER THAN EXPECTED VITROS AMON RESULTS WERE OBTAINED WHEN THE CUSTOMER PROCESSED A NON-VITROS BIORAD QUALITY CONTROL (QC) FLUID USING VITROS AMON LOT 1018-0255-4508 ON A VITROS 5600 INTEGRATED SYSTEM. THE ASSIGNABLE CAUSE OF THE EVENT CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED. HISTORICAL QC FOR VITROS AMON LOT 1018-0255-4508 WAS UNACCEPTABLE, HOWEVER A COMPLAINT REVIEW FOR VITROS AMON LOT 1018-0255-4508 INDICATED ONLY ONE ADDITIONAL COMPLAINT THAT WAS RESOLVED BY SERVICE ACTIONS. CONTINUAL TRACKING AND TRENDING DOES NOT INDICATE A SYSTEMIC ISSUE WITH VITROS AMON LOT 1018-0255-4508. A DIAGNOSTIC VITROS AMON PRECISION TEST WAS REQUESTED BY THE TSC BUT NOT COMPLETED BY THE CUSTOMER AT THE TIME OF THIS REPORT. THEREFORE, AN ISSUE WITH THE VITROS 5600 INTEGRATED SYSTEM CANNOT BE RULED OUT AS A CONTRIBUTOR TO THE EVENT. EMAIL ADDRESS FOR CONTACT OFFICE IS (B)(6).

    Description of Event or Problem · 1

    THE INVESTIGATION DETERMINED THAT HIGHER THAN EXPECTED VITROS AMMONIA (AMON) RESULTS WERE OBTAINED WHEN THE CUSTOMER PROCESSED A NON-VITROS BIORAD QUALITY CONTROL (QC) FLUID USING VITROS AMON LOT 1018-0255-4508 ON A VITROS 5600 INTEGRATED SYSTEM. BIORAD LOT 54302 VITROS AMON RESULTS OF 108.4, 104.4, 108.9, 118.5, 92.1, 99.5 AND 90.4 UMOL/L VERSUS THE BASELINE MEAN OF 74.76 UMOL/L. THE CUSTOMER OBTAINED THE LOWER THAN EXPECTED RESULT WHEN PROCESSING A NON-PATIENT FLUID. THERE WAS NO INDICATION PATIENT RESULTS WERE AFFECTED AROUND THE TIME OF THE EVENT. HOWEVER, THE INVESTIGATION COULD NOT RULE OUT PATIENT SAMPLES WOULD NOT BE AFFECTED IF THE EVENT WERE TO RECUR UNDETECTED. ORTHO WAS NOT MADE AWARE OF ANY ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT IS NUMBER FIVE OF SEVEN MDR¿S FOR THIS EVENT. SEVEN 3500A FORMS ARE BEING SUBMITTED FOR THIS EVENT AS SEVEN DEVICES WERE INVOLVED. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC (ORTHO) COMPLAINT NUMBER (B)(4) AND IVD (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    709258 VITROS CHEMISTRY PRODUCTS AMON SLIDES IN-VITRO DIAGNOSTICS JID ORTHO-CLINICAL DIAGNOSTICS 1018-0255-4508

    Patients

    Seq Age Sex Outcome Treatment
    1