BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABBOTT AXSYM SYSTEM

    MDR report key: 1488011 · Received September 30, 2009

    Report

    Report Number
    1628664-2009-00484
    Event Type
    Malfunction
    Date Received
    September 30, 2009
    Date of Event
    September 7, 2009
    Report Date
    September 8, 2009
    Manufacturer
    ABBOTT MANUFACTURING, INC.
    Product Code
    LEH
    PMA / PMN Number
    K950915
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION (B)(4) - OTHER A SINGLE DEFINITIVE CAUSE FOR THE ERRATIC RESULTS COULD NOT BE IDENTIFIED AS THE FIELD SERVICE REP REPLACED MULTIPLE COMPONENTS AND ADJUSTED AND TIGHTENED MULTIPLE CONNECTIONS. THE FIELD SERVICE REP (FSR) WAS REQUESTED TO VERIFY INSTRUMENT PERFORMANCE. THE FSR PERFORMED MULTIPLE PART REPLACEMENTS AND ADJUSTMENTS: THE REAGENT CAROUSEL V-WHEELS WERE REPLACED AS A PRECAUTION. THE V-WHEEL ASSEMBLY WAS CHANGED AT THE PROCESS CAROUSEL LEVEL AS A PRECAUTION AND HE CLEANED THE V-WHEEL ASSEMBLY AT THE RV CAROUSEL AND SAMPLE CAROUSEL. THE MATRIX CAROUSEL V-WHEELS WERE CHANGED AS A PRECAUTION. THE RV PICKER WAS CHANGED AS A PRECAUTION. THE ROTARY CAM WAS REPLACED AS IT WAS DAMAGED. THE BUFFER INLET TUBING KIT WAS REPLACED AS ONE OF THE TUBING WAS HALF BROKEN AT THE BUFFER TRANSFER PUMP UNION AND IT WAS LEAKING. THE BUFFER DELIVERY PUMP WAS FOUND BROKEN AT THE PLASTIC UNION OF THE BUFFER INLET TUBING. THE SYRINGE ASSEMBLY TUBING AT THE VALVE LEVEL WAS RESEATED AS IT WAS FOUND LOOSE. THE CONNECTION OF THE TUBING AT THE SYRINGE ASSEMBLY VALVE LEVEL WAS LOOSE AND THERE WERE SOME SALT DEPOSITS AT THE UNION AS IT WAS LEAKING. THE TUBING WAS RESEATED AND CONNECTED. THE REVIEW OF SERVICE HISTORY OF AXSYM (B)(4) INDICATES THERE WERE NO OTHER OCCURRENCES OF THE CUSTOMER DESCRIBED ISSUE FOLLOWING FIELD SERVICE VISIT ON (B)(6) 2009.

    Additional Manufacturer Narrative · 1

    THIS IS AN INITIAL REPORT. AN INVESTIGATION IS IN PROCESS. A FINAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    THE ACCOUNT STATED THAT THE AXSYM ANALYZER HAS GENERATED DISCREPANT VANCOMYCIN RESULTS ON 5 PATIENT SAMPLES. FOR PATIENT #3, THE INITIAL RESULT WAS 1.84 MG/L, THE RETEST RESULT WAS 13.20 MG/L. THE QC WAS WITHIN RANGE. THE ACCOUNT HAS DECIDED TO SEND OUT THEIR SAMPLES TO A REFERENCE LAB. THERE WAS NO ADVERSE IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ABBOTT AXSYM SYSTEM AUTOMATED IMMUNOASSAY ANALYZER LEH ABBOTT MANUFACTURING, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 VANCOMYCIN II REAGENT LIST 5B75-20 LOT 73470Q102| VANCOMYCIN II REAGENT LIST 5B75-20 LOT 73470Q102