BEUDAMED
    FDA Adverse Event Other Summary report: N

    AEROSET ANALYZER

    MDR report key: 654331 · Received December 16, 2005

    Report

    Report Number
    1628664-2005-00050
    Event Type
    Other
    Date Received
    December 16, 2005
    Date of Event
    November 23, 2005
    Report Date
    December 15, 2005
    Manufacturer
    ABBOTT MANUFACTURING, INC.
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER STATES THAT PT AEROSET ICT MODULE RESULTS GENERATE ACCEPTABLE RESULTS AT THE BEGINNING OF THE DAY BUT THEN BEGIN DRIFTING LOW OVER TIME. FOR EXAMPLE, ONE PT GENERATED RESULTS AS FOLLOWS: SODIUM = 119 MEQ/L, POTASSIUM = 3.8 MEQ/L, AND CHLORIDE = 107 MEQ/L. THE SAMPLE WAS THEN TESTED ON ANOTHER AEROSET ANALYZER IN THE LAB AND GENERATED THE FOLLOWING RESULTS: SODIUM = 144 MEQ/L, POTASSIUM = 3.8 MEQ/L, AND CHLORIDE = 107 MEQ/L. THE CUSTOMER STATES THAT NO SUSPECT RESULTS HAVE BEEN REPORTED FROM THE LAB AND THAT CONTROLS REMAIN WITHIN SPECIFICATIONS. THE CUSTOMER PERFORMED SEVERAL SUGGESTED TROUBLESHOOTING PROCEDURES AND PT RESULTS THEN BEGAN GENERATING HIGHER THAN EXPECTED RESULTS. AN INITIAL SERVICE CALL DID NOT RESOLVE THE ISSUE AND THE CUSTOMER IS REQUESTING FIELD SERVICE TO RETURN. 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