BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS 350 CHEMISTRY SYSTEM

    MDR report key: 11032189 · Received December 17, 2020

    Report

    Report Number
    1319681-2020-00125
    Event Type
    Malfunction
    Date Received
    December 17, 2020
    Date of Event
    November 29, 2020
    Report Date
    December 17, 2020
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT A LOWER THAN EXPECTED VITROS AMON RESULT WAS OBTAINED WHEN PROCESSING A VITROS LPV QUALITY CONTROL FLUID ON A VITROS 350 CHEMISTRY SYSTEM. THE ASSIGNABLE CAUSE OF THE EVENT WAS USER ERROR WITH USING AN AMMONIA BASED CLEANER WHICH SUBSEQUENTLY CAUSED MICROSLIDE INCUBATOR CONTAMINATION AND THE OBSERVED PERFORMANCE ISSUE WITH THE VITROS AMON ASSAY. AS PER THE VITROS 250/350 OPERATOR'S MANUAL; CLEANING SOLUTIONS: DO NOT USE ANY SOLVENTS OR CLEANING SOLUTIONS ON ANY PART OF THE VITROS® 250/350 SYSTEM, OTHER THAN DISTILLED OR DEIONIZED WATER. NEVER USE AMMONIA CLEANERS ON OR NEAR THE VITROS® 250/350 SYSTEM AN ORTHO FIELD ENGINEER (FE) PERFORMED SERVICE ACTIONS WHICH INCLUDED CLEANING THE MICROSLIDE INCUBATOR, EVAPORATION CAPS AND REPLACING THE WEAR PADS DUE TO WEAR. THE FE PERFORMED A WITHIN RUN VITROS AMON PRECISION TEST AND OBTAINED ACCEPTABLE RESULTS INDICATING THE VITROS 350 WAS PERFORMING AS EXPECTED. ALTHOUGH A PRECISION TEST WAS NOT COMPLETED PRIOR TO SERVICE ACTIONS TO ASSESS THE PERFORMANCE OF THE VITROS 350 SYSTEM, THE CUSTOMER CONFIRMED THAT THEY USE AMMONIA BASED CLEANER, AND DO NOT ROUTINELY CLEAN THE MICROSLIDE INCUBATOR EVAPORATION CAPS. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT A LOWER THAN EXPECTED VITROS AMON RESULT WAS OBTAINED WHEN PROCESSING A VITROS LIQUID PERFORMANCE VERIFIER (LPV) QUALITY CONTROL FLUID ON A VITROS 350 CHEMISTRY SYSTEM. LPV2, LOT Q8086 VITROS AMON RESULT 150.6 VERSUS THE MIDPOINT OF RANGE OF MEANS 193.7 UMOL/L. BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION. THE EVENT OCCURRED ON QUALITY CONTROL FLUIDS AND THE LABORATORY DISCONTINUED AMON PATIENT TESTING AS QUALITY CONTROL PERFORMANCE WAS UNACCEPTABLE. THERE WAS NO REPORTED ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1498967 VITROS 350 CHEMISTRY SYSTEM CHEMISTRY SYSTEM JJE ORTHO-CLINICAL DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1