BEUDAMED
    FDA Adverse Event Other Summary report: N

    ARCHITECT C8000

    MDR report key: 685777 · Received March 8, 2006

    Report

    Report Number
    2018433-2006-00001
    Event Type
    Other
    Date Received
    March 8, 2006
    Date of Event
    February 9, 2006
    Report Date
    February 9, 2006
    Manufacturer
    ABBOTT MANUFACTURING, INC
    Product Code
    JGJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER STATES THAT THE ARCHITECT C8000 ANALYZER IS GENERATING ERRATIC PATIENT RESULTS FOR THE MAGNESIUM ASSAY. THE LAB'S PROCEDURE IS TO RETEST ANY PATIENT RESULTS THAT ARE HIGH OR LOW AND HAVE BEEN NOTICING DIFFERENT RESULTS FOR SOME SAMPLES THAT ARE RETESTED. FOR EXAMPLE, ONE PATIENT GENERATED AN INITIAL RESULT OF 1.49 MMOI/L (2.98 MEG/L) THAT RETESTED AT 0.64 MMOI/L (1.28 MEQ/L). ANOTHER PATIENT SAMPLE GENERATED AN INITIAL RESULT OF 2.47 MMOI/L (4.94 MEQ/L) THAT RETESTED A 0.72 MMOI/L (1.44 MEQ/L). THE CUSTOMER STATES THAT THEY CALIBRATE THE MAGNESIUM ASSAY DAILY AND CONTROLS HAVE BEEN WITHIN SPECIFICATIONS. THERE IS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN