BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AEROSET ANALYZER

    MDR report key: 953134 · Received November 27, 2007

    Report

    Report Number
    1628664-2007-00559
    Event Type
    Malfunction
    Date Received
    November 27, 2007
    Date of Event
    November 1, 2007
    Report Date
    November 1, 2007
    Manufacturer
    ABBOTT LABORATORIES, 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

    AN ABBOTT FIELD SERVICE REPRESENTATIVE (FSR) WAS DISPATCHED TO INSPECT THE CUSTOMER'S INSTRUMENT AND FOUND ALL B-LINE NOZZLES WERE SEVERELY CLOGGED. THE B-LINE NOZZLES WERE CLEARED AND START-UP AND CONTROLS WERE PERFORMED TO VERIFY SYSTEM PERFORMANCE. NO FURTHER FOLLOW-UP OR PARTS WERE NEEDED. SUBSEQUENT INSTRUMENT OPERATIONS WERE ACCEPTABLE. THE CUSTOMER'S ISSUE IS ADDRESSED IN THE AEROSET PHOSPHORUS REAGENT PACKAGE INSERT (SPECIMEN COLLECTION AND HANDLING) AND THE AEROSET SYSTEM OPERATIONS MANUAL (P/N 200154-101: NOVEMBER 2004) IN SECTION 7 - OPERATIONAL PRECAUTIONS AND LIMITATIONS, IN SECTION 9 - SERVICE AND MAINTENANCE UNDER "OVERVIEW", AND IN SECTION 10 - TROUBLESHOOTING AND DIAGNOSTICS, UNDER OBSERVED PROBLEMS AND ERROR LOG MESSAGES. THIS IS A FINAL REPORT.

    Description of Event or Problem · 1

    THE CUSTOMER STATES THAT ERRATIC RESULTS ARE BEING GENERATED ON THE AEROSET ANALYZER. THE CUSTOMER GAVE THE GENERAL EXAMPLE OF PATIENT PHOSPHORUS ASSAY RESULTS INITIALLY READING 1.8 MG/DL AND RETESTING AT 3.8 MG/DL. CONTROLS WERE WITHIN SPECIFICATIONS EARLIER IN THE DAY. THE CUSTOMER REQUESTED A SERVICE CALL. 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 LABORATORIES, INC NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NI YR CLINICAL CHEMISTRY PHOSPHORUS ASSAY LIST#: 7D71-20| LOT#: UNK