BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS 5600 INTEGRATED SYSTEM

    MDR report key: 7716296 · Received July 24, 2018

    Report

    Report Number
    1319681-2018-00073
    Event Type
    Malfunction
    Date Received
    July 24, 2018
    Date of Event
    July 10, 2018
    Report Date
    July 24, 2018
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT A HIGHER THAN EXPECTED VITROS AMON RESULT WAS OBTAINED FROM A SINGLE VITROS LPV II CONTROL FLUID USING VITROS AMON REAGENT ON A VITROS 5600 INTEGRATED SYSTEM. THE MOST LIKELY ASSIGNABLE CAUSE OF THE HIGHER THAN EXPECTED VITROS AMON RESULT IS AN INSTRUMENT RELATED EVENT ASSOCIATED WITH MICRO SLIDE INCUBATOR CONTAMINATION. AFTER CLEANING THE MICRO SLIDE CM/RT ROTOR AND REPLACING THE INCUBATOR EVAPORATION CAPS, ACCEPTABLE VITROS AMON PERFORMANCE WAS OBTAINED.

    Description of Event or Problem · 1

    A CUSTOMER OBTAINED A HIGHER THAN EXPECTED VITROS AMON QUALITY CONTROL RESULT FROM A SINGLE VITROS LPV II FLUID CONTROL LEVEL USING VITROS AMON REAGENT ON A VITROS 5600 INTEGRATED SYSTEM. VITROS LPV II RESULT OF 235.1 UMOL/L VERSUS THE EXPECTED RESULT OF 193.9 UMOL/L. BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF PATIENT SAMPLES WERE AFFECTED. THE AFFECTED FLUIDS WERE NON-PATIENT SAMPLES. ORTHO HAS NOT BEEN MADE AWARE OF ANY ERRONEOUS VITROS AMON PATIENT SAMPLE RESULTS, 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 (ORTHO) INC. COMPLAINT NUMBER (B)(4) AND QERTS RECORD ID (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    559157 VITROS 5600 INTEGRATED SYSTEM CHEMISTRY ANALYZER JJE ORTHO-CLINICAL DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1