BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS 5,1 FS CHEMISTRY SYSTEM

    MDR report key: 8363806 · Received February 22, 2019

    Report

    Report Number
    1319681-2019-00016
    Event Type
    Malfunction
    Date Received
    February 22, 2019
    Date of Event
    February 1, 2019
    Report Date
    February 22, 2019
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT IMPRECISE QUALITY CONTROL (QC) RESULTS WERE OBTAINED FROM A NON-VITROS (BIORAD) FLUID USING VITROS AMON MICROSLIDES ON A VITROS 5,1 FS CHEMISTRY SYSTEM. THE INVESTIGATION CONCLUDED THE MOST LIKELY ASSIGNABLE CAUSE IS INSTRUMENT RELATED ASSOCIATED WITH MICROSLIDE INCUBATOR CONTAMINATION. AFTER CLEANING THE MICROSLIDE CM/RT INCUBATOR EVAPORATION CAPS; ACCEPTABLE VITROS AMON PERFORMANCE WAS OBTAINED.

    Description of Event or Problem · 1

    A CUSTOMER OBTAINED IMPRECISE QUALITY CONTROL (QC) RESULTS FROM A NON-VITROS (BIORAD) CONTROL FLUID USING VITROS AMON (AMMONIA) MICROSLIDES ON A VITROS 5,1 FS CHEMISTRY SYSTEM. BIORAD LOT 54223 (L3) RESULTS OF 135.2, 154, 158, 144, 175, 175, 160, 151, 168, 142, 154, 167, 149 AND 161 UMOL/L VS. THE EXPECTED RESULT OF 229.7 UMOL/L. BIASED RESULTS OF THE DIRECTION AND MAGNITUDE OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF UNDETECTED. THE IMPRECISE VITROS AMON RESULTS WERE GENERATED FROM A NON-PATIENT FLUID, HOWEVER THE INVESTIGATION CANNOT CONCLUDE THAT PATIENT SAMPLE RESULTS WERE NOT AFFECTED OR WOULD NOT BE AFFECTED IF THE EVENT WERE TO RECUR UNDETECTED. THERE WAS NO ALLEGATION OF ACTUAL PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC (ORTHO). COMPLAINT NUMBERS (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    157821 VITROS 5,1 FS CHEMISTRY SYSTEM CHEMISTRY ANALYZER JJE ORTHO-CLINICAL DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1