BEUDAMED
    FDA Adverse Event Other Summary report: N

    ARCHITECT C8000

    MDR report key: 938891 · Received November 8, 2007

    Report

    Report Number
    1628664-2007-00527
    Event Type
    Other
    Date Received
    November 8, 2007
    Date of Event
    October 17, 2007
    Report Date
    October 18, 2007
    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 COMPLETED.

    Description of Event or Problem · 1

    THE CUSTOMER STATES THAT A PATIENT SAMPLE TESTED USING THE ARCHITECT C8000 ANALYZER GENERATED A CLINICAL CHEMISTRY PHOSPHOROUS ASSAY RESULT OF 3.25 OF MMOL/L. THE RESULT WAS REPORTED OUT OF THE LAB AND SUBSEQUENTLY QUERIED. THE SAMPLE WAS REPEATED, YIELDING A RESULT OF 1.21 MMOL/L. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED. SERVICE WAS DISPATCHED TO THE CUSTOMER SITE TO TROUBLESHOOT THE ISSUE.

    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 YR CLINICAL CHEMISTRY PHOSPHORUS REAGENT| LOT NO. 49075HW00| LIST NO. 7D71-20