BEUDAMED
    FDA Adverse Event Other Summary report: N

    AEROSET ANALYZER

    MDR report key: 928966 · Received October 18, 2007

    Report

    Report Number
    1628664-2007-00457
    Event Type
    Other
    Date Received
    October 18, 2007
    Date of Event
    September 20, 2007
    Report Date
    September 20, 2007
    Manufacturer
    ABBOTT MANUFACTURING, INC
    Product Code
    JJE
    PMA / PMN Number
    K980367
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN ABBOTT FIELD SERVICE REPRESENTATIVE (FSR) WAS DISPATCHED TO INSPECT THE INSTRUMENT AND FOUND A POPPET VALVE NOT FUNCTIONING PROPERLY WHICH CAUSED THE WASH PUMP TO LEAK AT THE BELLOWS. THE POPPET VALVE WAS REPLACED AND A SUBSEQUENT RUN OF CONTROLS RECOVERED AS EXPECTED. REVIEW OF THE COMPLAINT HISTORY FOR AEROSET FOR THE TIME PERIOD 01/01/2007 THROUGH 10/15/2007 FOUND ONE ADDITIONAL COMPLAINT REGARDING PT RESULTS LOWER THAN EXPECTED THEN UPON REPEAT WERE ACCEPTABLE. THE FSR WAS DISPATCHED TO INSPECT THE INSTRUMENT RESOLVING THE ISSUE BY INSTALLING A NEW STYLE DEGASSER. A REVIEW OF TRENDING FOR THE AEROSET SYSTEM FOR JULY 2007 WAS PERFORMED. NO NEW DEFICIENCY RELATED TO THE ISSUE WAS IDENTIFIED THAT WOULD SUGGEST CONTINUED USE OF THIS PRODUCT WOULD CAUSE SOME TYPE OF ADVERSE HEALTH CONSEQUENCE OR THAT THE PRODUCT IS PERFORMING CONTRARY TO INTENDED USE OR LABEL CLAIMS. THE AEROSET SYSTEM OPERATIONS MANUAL (P/N 200154-101- NOVEMBER 2004) IN SECTION 10; TROUBLESHOOTING AND DIAGNOSTICS UNDER OBSERVED PROBLEMS, RESULTS ARE ERRATIC, PRECISION IS POOR, THE TEXT PROVIDES AS A PROBABLE CAUSE A MALFUNCTION OF THE CUVETTE WASHER AND DIRECTS THE CUSTOMER TO CONTACT THEIR ABBOTT REPRESENTATIVE FOR RESOLUTION. IN THIS CASE, THE CUSTOMER NOTED A LEAK IN FROM OF THE ANALYZER, WHICH THE FSR DETERMINED TO BE RELATED TO THE POPPETTE VALVE OF THE CUVETTE WASHER PUMP. THIS IS THE FINAL REPORT. END OF REPORT.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THE AEROSET ANALYZER WAS GENERATING PT RESULTS THAT WERE ABOUT HALF THE EXPECTED VALUES, WHICH APPEARED TO BE DUE TO A LEAKING PUMP. THE AFFECTED SAMPLES WERE TESTED ON THEIR OTHER ANALYZER AND RESULTS WERE AS EXPECTED. NO IMPACT TO PT MANAGEMENT WAS 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 NI YR