BEUDAMED
    FDA Adverse Event Other Summary report: N

    AEROSET ANALYZER

    MDR report key: 716055 · Received July 29, 2005

    Report

    Report Number
    1628664-2005-00033
    Event Type
    Other
    Date Received
    July 29, 2005
    Date of Event
    July 6, 2005
    Report Date
    July 27, 2005
    Manufacturer
    ABBOTT MANUFACTURING, INC.
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER STATES THAT ONE PT SAMPLE GENERATED AN INITIAL AEROSET CALCIUM ASSAY RESULT OF 17.5 MG/DL. THIS RESULT WAS REPORTED OUT OF THE LAB AND WAS NOT QUESTIONED BY THE PT'S PHYSICIAN. THE SAMPLE RETESTED ON THE SAME ANALYZER AT 12.1 AND 11.9 MG/DL. THE CUSTOMER ALSO STATED THAT A NUMBER OF ERROR CODES HAVE BEEN GENERATED BY THE ANALYZER: ERROR CODES 315- DAQ BOARD, 314- TRIGGER SENSOR AND 90- CYCLE DATA. NO PT INFORMATION IS AVAILABLE. THERE IS NO IMPACT TO PT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AEROSET ANALYZER AUTOMATED CHEMISTRY ANALYZER JJE ABBOTT MANUFACTURING, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN