BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AEROSET ANALYZER

    MDR report key: 1011332 · Received March 11, 2008

    Report

    Report Number
    1628664-2008-00071
    Event Type
    Malfunction
    Date Received
    March 11, 2008
    Date of Event
    February 13, 2008
    Report Date
    February 15, 2008
    Manufacturer
    ABBOTT MANUFACTURING, INC.
    Product Code
    JJE
    PMA / PMN Number
    K980367
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN ABBOTT FIELD SVC REP (FSR) VISITED THE CUSTOMER SITE AND FOUND THAT THE INTEGRATED CHIP TECHNOLOGY (ICT) MODULE ASPIRATION TUBING WAS CLOGGED. THE FSR REPLACED THE ICT MODULE'S ASPIRATION TUBING AND CALIBRATED ICT MODULE. SUBSEQUENT PRECISION AND CONTROLS RUNS WERE WITHIN SPECIFICATIONS. THE CUSTOMER REQUIRED NO FURTHER ASSISTANCE. THIS ISSUE IS ADDRESSED IN THE AEROSET SYS OPERATIONS MANUAL; 200155-101 - NOV 2004, IN THE SECTION(S) ENTITLED, RESULTS INTERPRETATION AND REPORTING AND THE TROUBLESHOOTING SECTION ENTITLED, ICT MODULE TUBING HAS BUBBLES. THIS IS A FINAL REPORT.

    Description of Event or Problem · 1

    THE CUSTOMER STATES THAT DISCREPANT RESULTS ARE BEING GENERATED ON PT SAMPLES ON THE AEROSET ANALYZER. THE CUSTOMER GAVE AN EXAMPLE OF ONE PT'S SAMPLE GENERATING AN INITIAL CREATININE ASSAY RESULT OF <0.2 MG/DL THAT RETESTED AT 0.9 MG/DL. THE CUSTOMER STATES THAT NO SUSPECT RESULTS WERE REPORTED FROM THE LAB. THE CUSTOMER REQUESTED A SVC CALL. THERE IS NO IMPACT TO PT MGMT 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 UNK AERO/C8K ICT MODULE LIST#: 9D28-03