BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS ECIQ IMMUNODIAGNOSTIC SYSTEM

    MDR report key: 1356014 · Received February 12, 2009

    Report

    Report Number
    1319681-2009-00034
    Event Type
    Malfunction
    Date Received
    February 12, 2009
    Date of Event
    January 16, 2009
    Report Date
    January 16, 2009
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THAT SIGNAL REAGENT CRYSTALS HAD BUILT UP ON THE SIGNAL REAGENT DISPENSE PROBES. THE CUSTOMER INDICATED THAT THEY HAD PERFORMED DAILY MAINTENANCE PER MANUFACTURER'S INSTRUCTIONS. OCD FIELD SERVICE INVESTIGATED AND REPLACED THE SIGNAL REAGENT DISPENSE TIPS AND PROBES. A LEAK WAS PERFORMED TO VERIFY SIGNAL REAGENT PUMPS WERE OPERATING AS EXPECTED. THE CUSTOMER PROCESSED QUALITY CONTROL FLUIDS SUCCESSFULLY WITH NO INCUBATOR FLOODING NOTED. THE ROOT CAUSE OF THE ANALYZER CONDITION CODES AND INCUBATOR FLOODING IS INSTRUMENT RELATED.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED OCD FOR ANALYZER CONDITION CODES ON THE VITROS ECIQ. SIGNAL REAGENT (SR) CRYSTALS WERE OBSERVED ON THE SR DISPENSE PROBES. POSSIBLE SR CONTAMINATION MAY PRODUCE BIASED RESULTS THAT COULD LEAD TO INAPPROPRIATE PHYSICIAN ACTION. THERE WERE NO ALLEGATIONS 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
    1 VITROS ECIQ IMMUNODIAGNOSTIC SYSTEM IMMUNODIAGNOSTIC SYSTEM JJE ORTHO-CLINICAL DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1