BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS EC Q IMMUNODIAGNOSTIC SYSTEM

    MDR report key: 946581 · Received November 14, 2007

    Report

    Report Number
    1319681-2007-00340
    Event Type
    Malfunction
    Date Received
    November 14, 2007
    Date of Event
    October 15, 2007
    Report Date
    October 16, 2007
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS, INC.
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    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. THE ROOT CAUSE OF THIS EVENT WAS A PARTIALLY OCCLUDED REAGENT METERING PROBE. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITROS EC Q IMMUNODIAGNOSTIC SYSTEM IMMUNDIAGNOSTIC ANALYZER JJE ORTHO-CLINICAL DIAGNOSTICS, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 YR