BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT C8000 SYSTEM

    MDR report key: 7707969 · Received July 20, 2018

    Report

    Report Number
    1628664-2018-00284
    Event Type
    Malfunction
    Date Received
    July 20, 2018
    Date of Event
    June 28, 2018
    Report Date
    August 9, 2018
    Manufacturer
    ABBOTT MANUFACTURING INC
    Product Code
    JJE
    UDI-DI
    00380740000509
    PMA / PMN Number
    K980367
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE TICKET INFORMATION FROM 28JUN2018 INDICATES THE CUSTOMER'S ISSUE WAS RESOLVED BY REPLACING THE ICT MODULE 180208017. A REVIEW OF COMPLAINTS FOR ICT MODULE, LOT 180208, FOUND NO OTHER COMPLAINTS. A REVIEW OF COMPLAINT AND TRENDING DATA FOR THE ICT MODULE, LIST NUMBER 9D28-03 DID NOT IDENTIFY ANY ISSUE OR TREND RELATED TO ERRATIC OR DISCREPANT RESULTS. A REVIEW OF TRENDING FOR CLINICAL CHEMISTRY SYSTEMS REVEALED NO ISSUES OR TRENDS RELATED TO THE CURRENT COMPLAINT. THE ARCHITECT SYSTEM OPERATIONS MANUAL AND THE ICT SAMPLE DILUENT PACKAGE INSERT PROVIDE ADEQUATE INFORMATION REGARDING SAMPLE HANDLING, PATIENT RESULT FLAGS, OPERATIONAL PRECAUTIONS AND LIMITATIONS OF RESULT INTERPRETATION, MAINTENANCE, COMPONENT REPLACEMENT, ERROR CODES, AND TROUBLESHOOTING FOR THE REPORTED ISSUE. BASED ON THE INVESTIGATION, NO PRODUCT DEFICIENCY WAS IDENTIFIED FOR THE ARCHITECT SERIAL NUMBER (B)(6), OR THE ICT MODULE, LIST NUMBER 09D28-03.

    Additional Manufacturer Narrative · 1

    AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. THERE IS NO FURTHER PATIENT INFORMATION PROVIDED BY THE CUSTOMER.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A FALSELY ELEVATED CHLORIDE RESULT ON ONE PATIENT. THE RESULTS PROVIDED WERE: ON (B)(6) 2018, SID: (B)(6), CHLORIDE = 110 /125MMOL/L. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    548675 ARCHITECT C8000 SYSTEM AUTOMATED CHEMISTRY ANALYZER JJE ABBOTT MANUFACTURING INC 00380740000509

    Patients

    Seq Age Sex Outcome Treatment
    1