BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABBOTT AXSYM SYSTEM

    MDR report key: 1061553 · Received June 17, 2008

    Report

    Report Number
    1628664-2008-00144
    Event Type
    Malfunction
    Date Received
    June 17, 2008
    Date of Event
    May 15, 2008
    Report Date
    May 23, 2008
    Manufacturer
    ABBOTT MANUFACTURING, INC.
    Product Code
    JJE
    PMA / PMN Number
    K950915
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE HISTORY OF THE CUSTOMER'S AXSYM ANALYZER FOUND THAT ON THE DATE IN QUESTION, ABBOTT WAS CONTACTED REGARDING ERROR CODE 5010, MOTOR STEP LOSS, SOLUTION 4 PUMP, SAMPLE CENTER. A FIELD SERVICE ENGINEER WAS DISPATCHED TO INSPECT THE INSTRUMENT AND FOUND THAT THE SAMPLE PROBE TIP WAS BENT AND DISPENSED IN ALL DIRECTIONS. THE PROBE WAS REPLACED TO RESOLVE THE ISSUE. A REVIEW OF COMPLAINT HISTORY FOR AXSYM WAS PERFORMED FOR THE TIME PERIOD OF 2008. ONE ADDITIONAL COMPLAINT WAS IDENTIFIED. THE COMPLAINT PREDATED THE CURRENT ISSUE AND DESCRIBED A BENT SAMPLE PROBE, WHICH COULD HAVE CAUSED THE ABERRANT HIV RESULTS. THE ABBOTT AXSYM SYSTEM OPERATIONS MANUAL VOLUME-2, MARCH 1999, SECTION 10, TROUBLESHOOTING AND DIAGNOSTICS, ADDRESSES ERROR CODE 5010 LISTING A PROBABLE CAUSE AS AN OBSTRUCTED PROBE AND PROVIDES CORRECTIVE ACTIONS TO TAKE. IN ADDITION, THIS SECTION DESCRIBES OBSERVED PROBLEMS; FPIA OR REA TEST RESULTS TOO HIGH/LOW. PROBABLE CAUSES INCLUDE A MALFUNCTION OF THE SAMPLING AND PROCESSING SYRINGE, VALVE, PROBE, AND PROBE LINK TUBING ASSEMBLIES AND DESCRIBES CORRECTIVE ACTIONS TO TAKE. THIS IS THE FINAL REPORT.

    Description of Event or Problem · 1

    THE CUSTOMER STATED A CLINIC NURSE QUESTIONED A NEGATIVE AXSYM 1/2 GO RESULT THAT WAS REPORTED ON A PATIENT WHO HAS TESTED POSITIVE ON A RAPID METHOD. UPON INVESTIGATION, THE CUSTOMER FOUND 11 PATIENTS HAD BEEN INCORRECTLY DIAGNOSED. THE CUSTOMER USED A RAPID TEST TO CONFIRM ALL RESULTS SENT OUT DURING THE DAY IN QUESTION. THE CUSTOMER RETESTED SOME OF THE PATIENTS ON AXSYM TO CONFIRM THE RAPID TEST RESULTS. FOUR PATIENTS PREVIOUSLY REPORTED AS NEGATIVE WERE CONFIRMED TO BE POSITIVE. ONE PATIENT PREVIOUSLY REPORTED AS NEGATIVE WAS CONFIRMED TO BE NEGATIVE. ONE PATIENT THAT WAS PREVIOUSLY NEGATIVE FOUND TO BE LOW POSITIVE. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NI LOT # 60047LF01| AXSYM HIV 1/2 GO REAGENT