BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT C8000

    MDR report key: 1000891 · Received February 21, 2008

    Report

    Report Number
    1628664-2008-00058
    Event Type
    Malfunction
    Date Received
    February 21, 2008
    Date of Event
    February 12, 2008
    Report Date
    February 12, 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 LIQUID LEVEL SENSE ERRORS HAVE BEEN OCCURRING FOR VARIOUS ASSAYS ON THE ARCHITECT C8000 ANALYZER. THE CUSTOMER GAVE ONE EXAMPLE OF AN INITIAL CALCIUM ASSAY RESULT OF 1.49 MMOL/L (5.96MG/DL) THAT RETESTED AT 2.33 MMOL/L (9.32 MG/DL) AND 2.38 MMOL/L (9.52MG/DL). NO SUSPECT RESULTS WERE REPORTED FROM THE LAB. THE CUSTOMER REQUESTED A SERVICE CALL. THERE IS NO IMPACT TO PT 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 UNK CLINICAL CHEMISTRY CALCIUM ASSAY LN: 7D61-20