BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS ECI Q IMMUNODIAGNOSTIC SYSTEM

    MDR report key: 1010172 · Received March 7, 2008

    Report

    Report Number
    1319681-2008-00065
    Event Type
    Malfunction
    Date Received
    March 7, 2008
    Date of Event
    February 6, 2008
    Report Date
    February 12, 2008
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT'S INVESTIGATION CONCLUDED THAT A PARTIAL OCCLUSION OF THE REAGENT METERING PROBE, THAT COULD IMPACT DELIVERY OF THE REAGENT FLUID, OCCURRED. THE OCD FIELD ENGINEER REPLACED THE REAGENT METERING PROBE. THE ROOT CAUSE OF THIS EVENT WAS A PARTIALLY OCCLUDED REAGENT METERING PROBE.

    Description of Event or Problem · 1

    THE CUSTOMER OBSERVED AN ANALYZER CONDITION CODE INDICATING THAT THE INSTRUMENT'S REAGENT METERING SUBSYSTEM WAS NOT PERFORMING OPTIMALLY. UNDER THESE CONDITIONS, ERRONEOUS RESULTS COULD BE OBTAINED WHICH COULD LEAD TO INAPPROPRIATE PHYSICIAN ACTION. THERE WAS NO REPORT OF PATIENT HARM AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITROS ECI Q IMMUNODIAGNOSTIC SYSTEM IMMUNODIAGNOSTIC ANALYZER JJE ORTHO-CLINICAL DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1