BEUDAMED
    FDA Adverse Event Other Summary report: N

    IMX ANALYZER

    MDR report key: 791693 · Received November 22, 2006

    Report

    Report Number
    1628664-2006-00093
    Event Type
    Other
    Date Received
    November 22, 2006
    Date of Event
    October 23, 2006
    Report Date
    November 6, 2006
    Manufacturer
    ABBOTT MANUFACTURING, INC.
    Product Code
    LCI
    PMA / PMN Number
    k864319
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DUE TO THE ISSUE, THE CUSTOMER PERFORMED AN IMX DISPENSE CHECK ON 11/03/2006 AND AN IMX MEIA PHOTO CHECK ON 11/06/2006. NO HARDWARE ISSUES WERE FOUND DURING THE DISPENSE AND MEIA PHOTO CHECKS. THE CUSTOMER STATED THAT THE IMX PROBE, MULTI-VALVE BLOCK, DILUENT AND SAMPLE SYRINGES WERE THREE YEARS OLD. THE CUSTOMER STATED THAT AFTER CHANGING THE DISPENSE COMPONENTS AND RECALIBRATING THE ASSAY, PATIENT AND CONTROL RESULTS WERE ACCEPTABLE. SERVICE HISTORY REVIEW FOR THE TIME PERIOD OF 11/01/2005 THROUGH 11/16/2006 INDICATES THERE HAVE BEEN NO OTHER COMPLAINTS OF INCONSISTENT RESULTS ON IMX. THE IMX SYSTEM OPERATIONS MANUAL (LN# 8376-07), SECTION 10, TROUBLESHOOTING, OBSERVED PROBLEMS, MEIA TEST RESULTS AND ERRATIC MEIA TEST RESULTS PROVIDES A LIST OF PROBABLE CAUSES AND CORRECTIVE ACTIONS TO RESOLVE THE ISSUE. DIRTY, DAMAGED OR INCORRECT POSITIONING OF THE PROBE/ELECTRODE ASSEMBLY AND DIRTY OR MALFUNCTIONING DISPENSE COMPONENTS ARE LISTED AS PROBABLE CAUSES AND REPLACING AND/OR RECALIBRATING DISPENSE COMPONENTS IS PROVIDED AS A CORRECTIVE ACTION. THIS IS THE FINAL REPORT.

    Description of Event or Problem · 1

    A PHYSICIAN QUESTIONED AN IMX B-HCG RESULT OF 89,650 MIU/ML ON A PREGNANT FEMALE PT. THE SAME SAMPLE WAS RETESTED YIELDING AN IMX B-HC RESULT OF 192,180 MIU/UL. 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 LOT NO. 45495Q100| IMX B-HCG REAGENT LIST NO. 1A06-22,