BEUDAMED
    FDA Adverse Event Other Summary report: N

    ABBOTT AXSYM SYSTEM

    MDR report key: 826282 · Received February 5, 2007

    Report

    Report Number
    1628664-2007-00003
    Event Type
    Other
    Date Received
    February 5, 2007
    Report Date
    January 12, 2007
    Manufacturer
    ABBOTT MANUFACTURING, INC.
    Product Code
    JJE
    PMA / PMN Number
    K950915
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER WAS INSTRUCTED TO REPLACE THE PROBE AND PERFORM A REPRODUCIBILITY TEST. THE REPRODUCIBILITY TEST WAS ACCEPTABLE. BASED ON THE AVAILABLE INFORMATION, THE EXACT CAUSE OF THE NEGATIVE BHCG RESULT COULD NOT BE DETERMINED. THE AXSYM ANALYZER PERFORMED ACCEPTABLY AFTER REPLACING THE PROBE. THE PATIENT SAMPLE WAS NOT RETESTED WITH THE NEW PROBE. THE AXSYM SYSTEM OPERATION MANUAL CONTAINS LABELING DESIGNED TO ASSIST THE CUSTOMER WITH INSTRUMENT TROUBLESHOOTING AND MAINTENANCE. SECTION 10: TROUBLESHOOTING AND DIAGNOSTICS, OBSERVED PROBLEMS, "RESULTS ERRATIC, DISCREPANT, AND/OR EXPERIENCING IMPRECISION" LISTS MULTIPLE PROBABLE CAUSES AND CORRECTIVE ACTIONS FOR INCONSISTENT RESULTS. CORRECTIVE ACTIONS LISTED IN THE OPERATIONS MANUAL ALSO REFER THE OPERATOR TO THE ASSAY-SPECIFIC PACKAGE INSERT FOR PROCESSING SAMPLES. THIS IS THE FINAL REPORT.

    Description of Event or Problem · 1

    THE ACCOUNT REPORTED A NEGATIVE AXSYM BHCG RESULT OF 0 IU/ML ON A PATIENT. MEDICS STATED THAT THE NEGATIVE RESULT WAS NOT PLAUSIBLE. A NEW SAMPLE WAS DRAWN FROM THE PATIENT AND A POSITIVE RESULT OF 192 IU/ML WAS GENERATED. THE INITIAL SAMPLE WAS RETESTED AND ALSO GENERATED A POSITIVE RESULT OF APPROXIMATELY 192 IU/ML. 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 YR AXSYM BHCG REAGENT LIST 7A59-21, LOT 45434Q101