BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT C8000 SYSTEM

    MDR report key: 1922606 · Received December 13, 2010

    Report

    Report Number
    1628664-2010-00480
    Event Type
    Malfunction
    Date Received
    December 13, 2010
    Date of Event
    November 7, 2010
    Report Date
    November 18, 2010
    Manufacturer
    ABBOTT MANUFACTURING, INC.
    Product Code
    JJE
    PMA / PMN Number
    K980367
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION WAS PROVIDED TO ABBOTT CUSTOMER SUPPORT. THE DISCREPANCY IN RESULTS PREVIOUSLY DOCUMENTED WAS FOR THE ICT SODIUM ASSAY. THE UPDATED INFORMATION WAS REVIEWED AND DOES NOT FIT ESTABLISHED CRITERIA FOR A REPORTABLE EVENT. THIS MDR (MANUFACTURER'S REPORT#: 1628664-2010-00480) WAS INADVERTENTLY FILED IN ERROR. THIS CORRECTED/UPDATED REPORT IS A FINAL REPORT. AN INVESTIGATION IS IN PROCESS.

    Additional Manufacturer Narrative · 1

    (B)(4). AN INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    THE CUSTOMER STATED AFTER INSTALLING A NEW ICT MODULE ON THE ARCHITECT C8000 ANALYZER, THERE HAVE BEEN OCCURRENCES OF HIGH CHLORIDE RESULTS. A RESULT OF 152 MMOL/L WAS REPORTED BUT THE ACTUAL VALUE WAS 129 MMOL/L. CHLORIDE RESULTS >120 MMOL/L ARE AUTOMATICALLY REPEATED AND THERE WAS NO REPORT OF IMPACT TO PATIENT MANAGEMENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 ICT SODIUM