BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABBOTT AXSYM SYSTEM

    MDR report key: 1061598 · Received June 17, 2008

    Report

    Report Number
    1628664-2008-00145
    Event Type
    Malfunction
    Date Received
    June 17, 2008
    Date of Event
    May 20, 2008
    Report Date
    May 20, 2008
    Manufacturer
    ABBOTT MFG, INC.
    Product Code
    JHS
    PMA / PMN Number
    K950915
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT TEST FOR ABBOTT AXSYM (LN07A83-01) DESCRIBES QUESTIONABLE CKMB RESULTS ON A PT. THE CUSTOMER ALSO COMPLAINED OF EC 5013 (MOTOR STEP LOSS, PROBE UP/DOWN, SAMPLING CENTER) AFTER REPLACING AND CALIBRATING THE PROCESSING PROBE. UPON REVIEW OF THE MESSAGE HISTORY LOG, THE CUSTOMER FOUND SAMPLING ERRORS, INCLUDING ERROR CODE 3083 LIQUID TOO LOW, SAMPLE CUP ADAPTOR. FIELD SERVICE WAS REQUESTED TO INSPECT AND SERVICE THE INSTRUMENT. THE FIELD SERVICE REP HAND TIGHTENED THE BLUE SAMPLE PROBE CLAMP THUMBSCREW, PERFORMED SAMPLE AND PROCESSING PROBE CALIBRATIONS AND A SUCCESSFUL FLUIDICS CHECK. THE SYSTEM OPERATED PROPERLY AFTER SERVICING. A REVIEW OF THE COMPLAINT HISTORY FOR ABBOTT AXSYM (LN 07A83-01) WAS PERFORMED FOR THE TIME PERIOD OF 3 MONTHS IN 2008. NO OTHER COMPLAINTS FOR THIS ISSUE WERE FOUND. THE CUSTOMER'S ISSUE IS ADDRESSED IN THE ABBOTT AXSYM SYSTEM OPERATIONS MANUAL VOLUME-2 VERSION 69-2949/R5 MARCH 1999 ON PAGE 10/252 (R4/R5) UNDER TROUBLESHOOTING AND DIAGNOSTICS, OBSERVED PROBLEMS SECTION 10, FPIA OR REA TEST RESULTS TOO HIGH/LOW. THE PROBABLE CAUSE(S) INCLUDE: INCORRECT POSITIONING OF THE SAMPLING PROBE OVER A TUBE SEGMENT. THE CORRECTIVE ACTIONS ARE: OBSERVE THE SAMPLING PROCESS DURING A RUN. IF THE PROBE TOUCHES ANY PORTION OF THE TUBE, VERIFY THE FOLLOWING: TUBE IS WITHIN AXSYM SYSTEM SPECIFICATIONS. SPRING IN SAMPLE SEGMENT HOLDS TUBE FIRMLY AND IN AN UPRIGHT POSITION. SAMPLING PROBE CHECK INDICATED PROPER ALIGNMENT IN A CUP. PERFORM SAMPLING PROBE CALIBRATION PROCEDURE. IN SECTION 10, UNDER TROUBLESHOOTING AND DIAGNOSTICS, LEVEL SENSE ERRORS 3000- 3999, 3083 LIQUID TOO LOW, SAMPLE CUP, SAMPLING CENTER IT LISTS THE PROBABLE CAUSE(S). ONE IS LEVEL SENSE CLIP LOOSE. THE CORRECTIVE ACTION IS TO CHECK THE BLUE KNURLED SCREW ON TOP OF THE PROBE TO VERIFY THAT IT IS FINGER-TIGHT. THIS IS A FINAL REPORT.

    Description of Event or Problem · 1

    THE CUSTOMER STATED QUESTIONABLE CK-MB RESULTS WERE GENERATED ON THE AXSYM ANALYZER. A PT WAS DRAWN AT APPROX 1:00 A.M. AND GENERATED A CK-MB RESULT OF 3.2NG/ML. THE PT WAS DRAWN 7 HOURS LATER YIELDING A CK-MB RESULT OF 0.9 NG/ML. THE CUSTOMER QUESTIONED THIS RESULT AND UPON RETEST, OBTAINED A CK-MB RESULT OF 3.9 NG/ML. THE RESULT OF 3.2 NG/ML WAS REPORTED TO THE PHYSICIAN. NO IMPACT TO PT MANAGEMENT WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NI AXSYM CK-MB REAGENT LIST #7A57-20 LOT #58400Q100