BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT C8000 SYSTEM

    MDR report key: 2628088 · Received June 25, 2012

    Report

    Report Number
    1628664-2012-00318
    Event Type
    Malfunction
    Date Received
    June 25, 2012
    Date of Event
    June 16, 2012
    Report Date
    June 18, 2012
    Manufacturer
    ABBOTT MANUFACTURING INC
    Product Code
    MZV
    PMA / PMN Number
    K980367
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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 AN ARCHITECT C8000 ANALYZER GENERATED A FALSELY ELEVATED POTASSIUM RESULT FOR ONE PATIENT SAMPLE. ABBOTT FIELD SERVICE REPLACED ALL OF THE CUVETTE WASH STATION NOZZLES, ADJUSTED THE WASH HEAD AND THE WASH CUP VOLUMES, REPLACED THE EXTERNAL WATER SUPPLY 25 MICRON FILTER AND THE R1 AND R2 PROBES AND TUBING, AND CONFIGURED A SMARTWASH FOR THE POTASSIUM ASSAY PARAMETERS. THE CUSTOMER REPLACED MIXER 1. FIELD SERVICE DID NOT IDENTIFY ANY OF THE REPLACED PARTS AS A LIKELY CAUSE FOR THE CUSTOMER'S ISSUE. THE SERVICE HISTORY INCLUDES NO RECURRENCE OF ICT ASSAY RESULT RELATED ISSUES. A REVIEW OF THE SYSTEM LOGS VERIFIED THE CUSTOMER'S ISSUE BUT DID NOT IDENTIFY A SPECIFIC CAUSE. TRACKING AND TRENDING DID NOT IDENTIFY ANY ISSUES OR ADVERSE TRENDS RELATED TO THE COMPLAINT. LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE. BASED ON THE AVAILABLE INFORMATION A DEFICIENCY OF THE ARCHITECT C8000 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

    THE CUSTOMER STATED AN ARCHITECT C8000 ANALYZER GENERATED A FALSELY ELEVATED POTASSIUM RESULT FOR ONE PATIENT SAMPLE. THE ARCHITECT GENERATED A POTASSIUM RESULT OF 6.0. THE SAMPLE WAS REPEATED AND A POTASSIUM RESULT OF ABOUT 3.9 WAS GENERATED. THE FALSELY ELEVATED POTASSIUM RESULT WAS NOT REPORTED OUTSIDE THE LABORATORY AND THERE WAS NO ADVERSE IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 POTASSIUM| POTASSIUM