BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACCELERATOR APS

    MDR report key: 922263 · Received October 4, 2007

    Report

    Report Number
    1628664-2007-00445
    Event Type
    Other
    Date Received
    October 4, 2007
    Date of Event
    September 11, 2007
    Report Date
    September 11, 2007
    Manufacturer
    ABBOTT MANUFACTURING INC.
    Product Code
    JQW
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACCELERATOR APS USER GUIDE DOES NOT PROVIDE SPECIFIC INFORMATION TO ADDRESS THE SCENARIO. IT DOES PROVIDE INFORMATION RELATED TO PROCEDURE THAT REQUIRE THE SYSTEM TO BE IN THE OFF-LINE STATE AND ALSO FOR ADDRESSING WARNINGS AND ERROR MESSAGES THAT MAY BE GENERATED DURING NORMAL OPERATION: CONFIGURATION SYSTEM (ON-LINE/OFF-LINE). PERFORM THE FOLLOWING PROCEDURE TO TURN A WORKCELL MODULE ON-LINE OR OFF-LINE. WARNING: CHANGING THE ON-LINE/OFF-LINE STATUS OF A WORKCELL MODULE OR INSTRUMENT CHANGES THE PROCESSING CONFIGURATION OF THE WORKCELL. ENSURE TUBES IN THE INPUT LANES ARE APPROPRIATE FOR THE CHANGED WORKCELL CONFIGURATION. THE USER GUIDE ALSO PROVIDES INFORMATION REGARDING HOW THE SYSTEM RESPONDS WHEN IN THE OFF-LINE STATE FOR VARIOUS COMPONENTS OF THE SYSTEM. THIS IS AN INITIAL REPORT. AN INVESTIGATION IS IN PROCESS. A FINAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    AN ABBOTT IN-HOUSE INVESTIGATION ON THE ACCELERATOR AUTOMATED PROCESSING SYSTEMS (APS) INPUT/OUTPUT MODULE (IOM) FOUND THAT SAMPLE PRESENTATION/SAMPLE QUEUE ERRORS ARE NOT CONSISTENTLY REPORTED WHEN THE ANALYZER IS PUT OFF-LINE: IF THE ANALYZER IS PUT OFF-LINE WHILE A SAMPLE PRESENTATION ERROR OCCURS, THE SAMPLE PRESENTATION ERROR IS REPORTED ONLY AFTER THE ANALYZER IS PUT ON-LINE AGAIN, WHILE THE SAMPLE QUEUE ERROR IS NOT REPORTED. IF THE ANALYZER IS PUT OFF-LINE WHILE THE ANALYZER IS SAMPLING (WITHOUT ANY SAMPLE PRESENTATION ERRORS), THE APS REPORTS A FALSE SAMPLE PRESENTATION ERROR WHEN THE ANALYZER IS PUT BACK ON-LINE. THESE SCENARIOS PROVIDE THE POSSIBILITY THAT THE TESTS ORDERED FOR ONE SAMPLE MAY BE ASPIRATED FROM A DIFFERENT SAMPLE WITHOUT ANY ERROR BEING GENERATED. ALSO, THE POSSIBILITY EXISTS FOR SAMPLE CONTAMINATION SINCE THE PROBE MAY CARRYOVER SAMPLE FROM ONE TUBE TO THE NEXT. TO DATE, THERE HAS BEEN NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCELERATOR APS AUTOMATED SAMPLE HANDLING AND PROCESSING SYSTEM JQW ABBOTT MANUFACTURING INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NI YR