BEUDAMED
    FDA Adverse Event Other Summary report: N

    IMX ANALYZER

    MDR report key: 786187 · Received November 3, 2006

    Report

    Report Number
    1628664-2006-00086
    Event Type
    Other
    Date Received
    November 3, 2006
    Date of Event
    October 5, 2006
    Report Date
    October 11, 2006
    Manufacturer
    ABBOTT MANUFACTURING, INC.
    Product Code
    LCI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO TROUBLESHOOT THE ISSUE, THE CUSTOMER PERFORMED A BUFFER RUN AND IDENTIFIED SPLASHING AT THE PREDILUTION WELL. THE CUSTOMER DECIDED TO CHANGE THE PROBE AND PERFORM BOOM CALIBRATION WITH LEVEL SENSE AND REPEAT THE BUFFER RUN. AFTER REPLACING THE PROBE, THE CUSTOMER PERFORMED A BUFFER RUN AND WAS UNABLE TO GET A PASSING LEVEL SENSE. ABBOTT FIELD SERVICE WAS THEN REQUESTED TO RESOLVE THE ISSUE. ABBOTT FIELD SERVICE REPLACED THE MULTIVALVE BLOCK AND THE SAMPLE AND DILUENT SYRINGES WITH INTERCONNECT TUBINGS. UPON FOLLOW-UP BY ABBOTT, THE CUSTOMER STATED THAT THE LEVEL SENSE WAS STILL NOT RESOLVED AND ABBOTT FIELD SERVICE WAS DISPATCHED AGAIN TO EVALUATE THE IMX ANALYZER. NO PROBLEM WAS OBSERVED. SERVICE WAS UNABLE TO VERIFY THE ISSUE. TO OPTIMIZE THE SYSTEM, THE ABBOTT FIELD SERVICE REPRESENTATIVE LUBRICATED THE BOOM SHAFTS AND ADJUSTED THE BOOM LEVELS. A DISPENSE CHECK, MEIA PHOTOCHECK, AND PRECISION RUN ON THE B-HCG LOW CONTROL PASSED. THE CUSTOMER STATED THAT THE ANALYZER IS NOW RUNNING TO THE LABORATORY'S EXPECTATION. SINCE MULTIPLE COMPONENTS WERE REPLACED AND MAINTENANCE PROCEDURES WERE PERFORMED, THE EXACT CAUSE OF THE ERRATIC RESULTS COULD NOT BE DETERMINED. THIS IS THE FINAL REPORT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED AN IMX BHCG RESULT OF 8078 MLU/ML ON A FEMALE PATIENT. THE SAMPLE WAS RETESTED FOUR DAYS LATER AND THE IMX BHCG RESULT WAS 22128 MLY/ML. THE SAMPLE WAS SENT TO A REFERENCE LABORATORY FOR TESTING WHICH CONFIRMED THE REPEAT IMX RESULT. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN IMX BHCG REAGENT LIST 1A06-22, LOT 41369Q101