BEUDAMED
    FDA Adverse Event Other Summary report: N

    ARCHITECT C8000

    MDR report key: 610744 · Received June 3, 2005

    Report

    Report Number
    1628664-2005-00023
    Event Type
    Other
    Date Received
    June 3, 2005
    Report Date
    May 31, 2005
    Manufacturer
    ABBOTT MANUFACTURING INC.
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER OBSERVED ARCHITECT C8000 IMPRECISION WHILE TESTING PT SAMPLES. AN INITIAL CALCIUM RESULT OF 2.0 MMOL/L RETESTED AT 1.08 MMOL/L. SINCE THE CUSTOMER QUESTIONED THESE LOW RESULTS, THE SAMPLE WAS TESTED A THIRD TIME YIELDING A RESULT OF 2.28 MMOL/L. NO IMPACT TO THE PT MANAGEMENT WAS 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 UNKNOWN