BEUDAMED
    FDA Adverse Event Other Summary report: N

    IMX ANALYZER

    MDR report key: 422335 · Received October 9, 2002

    Report

    Report Number
    1628664-2002-00055
    Event Type
    Other
    Date Received
    October 9, 2002
    Date of Event
    September 23, 2002
    Report Date
    October 9, 2002
    Manufacturer
    ABBOTT MANUFACTURING, INC.
    Product Code
    LCI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A PHYSICIAN QUESTIONED AN INITIAL IMX BHCG ASSASY RESULT OF 914 MLU/ML. THE PATIENT (POSSIBLE ECTOPIC PREGNANCY) WAS REDRAWN AND TESTED TWO DAYS LATER AND GENERATED A RESULT OF 5580.10 MLU/ML. AN ULTRASOUND WAS PERFORMED AND CONFIRMED A VIABLE PREGNANCY. THE INITIAL SAMPLE WAS RETESTED AND GENERATED A RESULT OF 3124 MLU/ML. ALL CONTROLS WERE WITHIN SPECIFICATIONS ON ALL RUNS. THERE IS NO IMPACT TO PATIENT MANAGEMENT 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 NO INFO MIX TOTAL BHCG ASSAY LIST 1A06-22 LOT 88424Q100| 88424Q100.| IMX TOTAL BHCG ASSAY, LIST 8389-59, LOT