BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT C8000 SYSTEM

    MDR report key: 2621467 · Received June 19, 2012

    Report

    Report Number
    1628664-2012-00312
    Event Type
    Malfunction
    Date Received
    June 19, 2012
    Date of Event
    June 1, 2012
    Report Date
    June 1, 2012
    Manufacturer
    ABBOTT MANUFACTURING INC
    Product Code
    CGZ
    PMA / PMN Number
    K980367
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FURTHER INVESTIGATION OF THE CUSTOMER ISSUE INCLUDED A REVIEW OF THE COMPLAINT TEXT, A SEARCH FOR SIMILAR COMPLAINTS, AND A REVIEW OF LABELING. THE CUSTOMER STATED THE ARCHITECT C8000 ANALYZER GENERATED A FALSELY DECREASED CHLORIDE RESULT FOR ONE PATIENT SAMPLE. WATER WAS OBSERVED DRIPPING ONTO THE CUVETTES FROM THE REAGENT CAROUSEL. THE ABBOTT FIELD SERVICE REPRESENTATIVE (FSR) REPLACED THE BELLOWS AND POPPET VALVES ON THE CUVETTE WASH AND HIGH CONCENTRATION WASTE PUMPS. THE SHEET VALVE AND DIAPHRAGMS FOR THE VACUUM PUMPS WERE ALSO REPLACED. ADDITIONALLY, THE FSR INDICATED THAT PROBE 4 TUBING WAS PARTIALLY BLOCKED AND THE TUBING WAS CLEANED IN ORDER TO REMOVE THE BLOCKAGE. AFTER THIS MAINTENANCE THE FSR INDICATED THE ISSUE WAS RESOLVED. TRACKING AND TRENDING REVEALED NO ADVERSE OR NON-STATISTICAL TREND OR PRODUCT ISSUE ASSOCIATED WITH THE CUSTOMER'S COMPLAINT. LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE. BASED ON THE AVAILABLE INFORMATION A DEFICIENCY WAS NOT IDENTIFIED.

    Additional Manufacturer Narrative · 1

    (B)(4). A FOLLOW UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Description of Event or Problem · 1

    AN ARCHITECT C8000 ANALYZER GENERATED A FALSELY DECREASED CHLORIDE RESULT FOR ONE PATIENT SAMPLE. THE ARCHITECT GENERATED AN INITIAL CHLORIDE RESULT OF 78 AND A REPEAT VALUE OF 95. THERE WAS NO ADVERSE IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARCHITECT C8000 SYSTEM CGZ ABBOTT MANUFACTURING INC

    Patients

    Seq Age Sex Outcome Treatment
    1 ICT CHLORIDE| ICT CHLORIDE