BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AEROSET ANALYZER

    MDR report key: 999068 · Received February 18, 2008

    Report

    Report Number
    1628664-2008-00050
    Event Type
    Malfunction
    Date Received
    February 18, 2008
    Date of Event
    February 5, 2008
    Report Date
    February 7, 2008
    Manufacturer
    ABBOTT MANUFACTURING, INC
    Product Code
    JJE
    PMA / PMN Number
    K980367
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    QUARTERLY MAINTENANCE WAS LAST PERFORMED IN 2007, AND ALL OTHER INSTRUMENT MAINTENANCE WAS CURRENT. THE SAMPLE PROBES WERE REPLACED WITHIN THE LAST TWO WEEKS, THE REAGENT PROBES WERE REPLACED WITHIN THE LAST YR, AND THE POPPET VALVES HAD RECENTLY BEEN REPLACED. THE CUSTOMER SUPPORT SPECIALIST INSTRUCTED THE CUSTOMER TO COMPLETE QUARTERLY MAINTENANCE, REPLACE ALL REAGENT PROBES AND POPPET VALVES. THE FIELD SERVICE REPRESENTATIVE WAS DISPATCHED AND REPLACED THE SAMPLE ARM B SHAFT TUBING, RAN PRECISION, AND CONTROLS PASSED. SUBSEQUENT INSTRUMENT OPERATION AND TEST RESULTS WERE ACCEPTABLE. THIS ISSUE IS ADDRESSED IN THE CLINICAL CHEMISTRY CALCIUM REAGENT PACKAGE INSERT (30-3979/R5) IN THE SECTIONS ENTITLED, SPECIMEN COLLECTION AND HANDLING AND REAGENT HANDLING AND STORAGE. THE AEROSET SYSTEM OPERATIONS MANUAL (P/N 200154-101- 2004) ALSO ADDRESSES THIS ISSUE IN SECTION 7, OPERATIONAL PRECAUTIONS AND LIMITATIONS UNDER THE HEADING ENTITLED, RESULTS INTERPRETATION AND REPORTING. A MALFUNCTION OF THE SYSTEM WAS IDENTIFIED. THE ISSUE WAS DETERMINED TO BE RELATED TO A WORN SAMPLE ARM B SHAFT TUBING, WHICH WAS RESOLVED BY THE FIELD SERVICE REPRESENTATIVE. THIS IS A FINAL REPORT.

    Description of Event or Problem · 1

    THE CUSTOMER STATES THAT THE AEROSET ANALYZER IS INITIALLY GENERATING LOWER THAN EXPECTED PT RESULTS FOR VARIOUS ASSAYS THAT UPON RETEST GENERATE EXPECTED (HIGHER) RESULTS. THE CUSTOMER GAVE THE EXAMPLE OF A CALCIUM ASSAY INITIAL RESULT OF 3.0 MG/DL THAT RETESTED AT 9.0 MG/DL. THE CUSTOMER STATES THAT THIS IS AFFECTING MAINLY B-LINE ASSAYS. THE CUSTOMER STATES THAT NO SUSPECT PT RESULTS WERE REPORTED FROM THE LAB AND WAS UNWILLING TO PROVIDE ANY FURTHER INFO. THE ABBOTT CUSTOMER SERVICE ADVOCATE (CTA) SUGGESTED A NUMBER OF TROUBLESHOOTING PROCEDURES TO TRY WITH NO RESOLUTION. A SERVICE CALL WAS INITIATED. 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 NI LOT # UNK| CLINICAL CHEMISTRY CALCIUM ASSAY LIST # 7D61-20