BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT C8000

    MDR report key: 1030583 · Received April 16, 2008

    Report

    Report Number
    1628664-2008-00097
    Event Type
    Malfunction
    Date Received
    April 16, 2008
    Date of Event
    March 20, 2008
    Report Date
    March 24, 2008
    Manufacturer
    ABBOTT MANUFACTURING, INC.
    Product Code
    JJE
    PMA / PMN Number
    K980367
    Removal / Correction Number
    UNK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ABBOTT FIELD SERVICE REPRESENTATIVE NOTICED THAT THE CLEAR INNER PLUGGER SHIELD FOR THE WASH SOLUTION WAS LOOSE. HE RETIGHTENED THE PART AND SUCCESSFULLY CALIBRATED THE MAGNESIUM ASSAY WITH ALL CONTROLS WITHIN SPECIFICATIONS. THE ALKALINE AND ACID WASH SYRINGE BLOCK WAS ALSO COMPLETELY LOOSE. THE CUSTOMER TIGHTENED THE BLOCK AND AFTERWARDS SUCCESSFULLY RAN THE ANALYZER. THE CAUSE OF THE LOOSE SYRINGE BLOCK, WHETHER USER ERROR DURING MAINTENANCE OR COMPONENT WEAR, CANNOT BE DETERMINED FROM THE DATA GIVEN. SUBSEQUENT INSTRUMENT OPERATIONS AND TEST RESULTS WERE ACCEPTABLE. THIS ISSUE IS ADDRESSED IN THE ABBOTT ARCHITECT SYSTEM OPERATIONS MANUAL (PN 96211-107) JUNE, 2007, SECTION 10-573: TROUBLESHOOTING AND DIAGNOSTICS - OBSERVED PROBLEMS. THIS IS A FINAL REPORT. END OF REPORT.

    Description of Event or Problem · 1

    THE CUSTOMER STATES THAT DISCREPANT RESULTS ARE BEING GENERATED BY THE ARCHITECT C8000 ANALYZER. PATIENT #3 GENERATED THE FOLLOWING RESULTS: RESULTS WERE QUESTIONED BY PHYSICIANS. A SERVICE CALL WAS INITIATED. THERE IS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARCHITECT C8000 AUTOMATED CHEMISTRY ANALYZER JJE ABBOTT MANUFACTURING, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NI POTASSIUM| CHLORIDE| CO2| GLUCOSE| PHOSPHORUS| SODIUM| T. BILIRUBIN| CREATININE| CALCIUM| MAGNESIUM| ICT MODULE