BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AEROSET ANALYZER

    MDR report key: 961064 · Received December 10, 2007

    Report

    Report Number
    1628664-2007-00580
    Event Type
    Malfunction
    Date Received
    December 10, 2007
    Date of Event
    November 14, 2007
    Report Date
    November 14, 2007
    Manufacturer
    ABBOTT MANUFACTURING, INC.
    Product Code
    JJE
    PMA / PMN Number
    K980367
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ABBOTT FIELD SERVICE REP (FSR) CLEANED THE WASH CUPS, CLEANED AND ALIGNED THE CUVETTE WASHER TO ADDRESS OVERFLOW AND REPLACED 1 ML SYRINGES. THE FSR ADVISED CUSTOMER ON THE NEED TO COMPLETE QUARTERLY MAINTENANCE. THE CUSTOMER CALLED BACK TO REPORT THE ISSUE WAS NOT RESOLVED. THE FSR RETURNED TO REPLACED THE ICT MODULE AND TUBING. THE SYSTEM WAS CALIBRATED SUCCESSFULLY. THE FSR RAN CONTROLS AND PERFORMED A PRECISION RUN WITH ACCEPTABLE RESULTS TO RESOLVE THE ISSUE. THE CUSTOMER ISSUE IS ADDRESSED IN THE AEROSET CUSTOMER TRAINING SUPPLEMENT-ICT PREVENTIVE MAINTENANCE (95132-101-FEBRUARY 2003) WITH INFO RELATED TO ADDRESSING ICT CONCERNS AND THE AEROSET SYSTEM OPERATIONS MANUAL (200155-101-NOVEMBER 2004) IN THE SECTIONS ENTITLED: SECTION 7- OPERATIONAL PRECAUTIONS AND LIMITATIONS, SECTION 9- SERVICE AND MAINTENANCE, AND SECTION 10- TROUBLESHOOTING AND DIAGNOSTICS. A MALFUNCTION OF THE SYSTEM OCCURRED DUE TO MULTIPLE ISSUES (DIRTY CUVETTE DRYER TIPS AND MIXER WASH CUPS AND LEAKING WAS PUMP SYRINGES). ALTHOUGH THE ISSUE RETURNED AFTER THE INITIAL FIELD SERVICE INTERVENTION, RESOLUTION CAME WITH THE REPLACEMENT OF THE SYRINGES, TUBING AND ICT MODULE. IT SHOULD BE NOTED THAT ON THIS OCCASION THE FSR ADVISED THE CUSTOMER TO COMPLETE QUARTERLY MAINTENANCE WHICH WAS NOT DOCUMENTED TO HAVE BEEN COMPLETED FOR THIS INSTANCE OF ANY OTHER BASED ON COMPLAINT HISTORY REVIEW. THIS IS THE FINAL REPORT.

    Description of Event or Problem · 1

    THE CUSTOMER STATES THAT ERRATIC PT RESULTS ARE BEING GENERATED BY THE AEROSET SODIUM ASSAY. ONE PT RESULTS OF 126 MMOL/L WAS REPORTED OUT OF THE LAB. WHEN THIS LOW RESULT WAS NOTICED, THE SAME SAMPLE WAS TESTED ON ANOTHER AEROSET ANALYZER IN THE LAB AND GENERATED A RESULT OF 141 MMOL/L AND A CORRECTED REPORT WAS ISSUED. THE CUSTOMER THEN RAN A 10 POINT PRECISION RUN WITH THE FOLLOWING RESULTS: 123, 135, 131, 135, 119, 134, 134, 130, 131, AND 135 MMOL/L. UPON EXAMINING THE AEROSET ANALYZER IN QUESTION, THE CUSTOMER NOTICED THAT THE CUVETTE WIPERS AND MIXER CUPS ARE DIRTY AND THAT THE WASH PUMP SYRINGES ARE LEAKING. THE CUSTOMER DECLINED TO TROUBLESHOOT WITH THE CUSTOMER TECHNICAL ADVOCATE AND IS REQUESTING A SERVICE CALL. THERE IS NO IMPACT TO PT MGMT REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK YR LIST #:9D28-03| AERO/C8K ICT MODULE