BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT C8000

    MDR report key: 1000890 · Received February 21, 2008

    Report

    Report Number
    1628664-2008-00059
    Event Type
    Malfunction
    Date Received
    February 21, 2008
    Report Date
    February 14, 2008
    Manufacturer
    ABBOTT MANUFACTURING INC
    Product Code
    JJE
    PMA / PMN Number
    K980367
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS AN INITIAL REPORT. AN INVESTIGATION IS IN PROCESS. A FINAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    THE CUSTOMER STATES THAT ONE PT SAMPLE GENERATED AN INITIAL ARCHITECT C8000 POTASSIUM ASSAY RESULT OF GREATER THAN 10.0 MMOL/L. THE SAMPLE RETESTED AT 4.52 MMOL/L ON THIS C8000 ANALYZER AND AT 4.35 MMOL/L ON A DIFFERENT INSTRUMENT. A SERVICE CALL WAS INITIATED.

    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 UNK AERO/C8K ICT MODULE LIST# 9D28-03