BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITROS ECIQ IMMUNODIAGNOSTIC SYSTEM

    MDR report key: 1744322 · Received July 1, 2010

    Report

    Report Number
    1319681-2010-00128
    Event Type
    Malfunction
    Date Received
    July 1, 2010
    Date of Event
    June 1, 2010
    Report Date
    July 1, 2010
    Manufacturer
    ORTHO-CLINICAL DIAGNOSTICS
    Product Code
    MMI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION DETERMINED THE (B)(4) CODES WERE CAUSED BY CONTAMINATED SIGNAL REAGENT (SR) PROBES SUPPRESSING THE ASSAY WELL SIGNAL. IF THE ASSAY WELL SIGNAL IS BELOW THE ASSAY SIGNAL THRESHOLD, A (B)(4) CONDITION CODE WILL BE POSTED BY THE SYSTEM AND THE RESULT WILL BE SUPPRESSED. THE WASTE TUBING FROM THE SR PRIME/PURGE STATION HAD BECOME DISCONNECTED ALLOWING THE SR PROBES TO BE SUBMERGED IN WASTE SR FLUID DURING A PRIME/PURGE CYCLE ALLOWING SR FLUID TO DRY AND CRYSTALLIZE ON THE SR PROBES. RE-HYDRATION OF THE DRIED SR CRYSTALS IN AN ASSAY WELL WILL SUPPRESS THE ASSAY WELL SIGNAL. DESPITE REGULAR MAINTENANCE BY THE CUSTOMER, THIS DISCONNECTED SR WASTE TUBING WAS NOT DETECTED. FOLLOWING REPAIRS, THE SYSTEM WAS RETURNED TO EXPECTED OPERATION. THERE IS NO EVIDENCE THAT PATIENT RESULTS WERE AFFECTED, HOWEVER THE INVESTIGATION CANNOT CONCLUDE THAT PATIENT RESULTS WOULD NOT BE AFFECTED POTENTIALLY LEADING TO INAPPROPRIATE PHYSICIAN ACTIONS.

    Description of Event or Problem · 1

    THE CUSTOMER OBSERVED THE SUDDEN OCCURRENCE OF (B)(4) CONDITION CODES GENERATED BY THE VITROS ECI Q IMMUNODIAGNOSTIC SYSTEM. THE (B)(4) CONDITION CODES SUPPRESSED SEVERAL PATIENT RESULTS. THE OCCURRENCE OF (B)(4) CONDITION CODES MAY BE INDICATIVE OF ANALYZER ISSUES THAT COULD CAUSE BIASED PATIENT RESULTS LEADING TO POTENTIAL INAPPROPRIATE PHYSICIAN ACTIONS. THERE WAS NO EVIDENCE THAT PATIENT RESULTS WERE AFFECTED, AND THERE WAS NO ALLEGATION OF PATIENT HARM. 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 ANALYZER MMI ORTHO-CLINICAL DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1