BEUDAMED
    FDA Adverse Event Other Summary report: N

    IMX ANALYZER

    MDR report key: 173061 · Received June 15, 1998

    Report

    Report Number
    1628664-1998-00056
    Event Type
    Other
    Date Received
    June 15, 1998
    Date of Event
    May 19, 1998
    Report Date
    June 11, 1998
    Manufacturer
    ABBOTT MFG, INC.
    Product Code
    LCI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SVC REP (FSR) VISITED THE ACCOUNT TO EVALUATE THE SYS. THE OPTICS WERE REPLACED BY THE FSR, AND THE MEIA PHOTO CALIBRATION, CAROUSEL CALIBRATION AND DISPENSE CHECK WERE PERFORMED. PRECISION RUNS WERE ALSO PERFORMED ON DILUTED SPECIMENS AND ALL CVS WERE </=6%, WHICH IS REPRESENTED IN THE ASSAY LABEL CLAIMS (TOTAL B-HCG PACKAGE INSERT, MARCH 1996). ANALYSIS OF TRENDING WAS PERFORMED. NO ADVERSE TRENDS WERE OBSERVED WITHIN 12 MOS DATA OF OVERALL COMPLAINTS ON THE IMX ANALYZER. THIS IS THE FINAL REPORT.

    Description of Event or Problem · 1

    ON 5/19/1998 THE ACCOUNT REPORTED A DISCREPANT IMX TOTAL BETA HUMAN CHORIONIC GONADOTROPIN RESULT AND THE PT WAS SCHEDULED FOR A DILATATION AND CURETTAGE BECAUSE OF THE RESULT. THE SPECIMEN WAS RUN IN DILUTION MODE ON 5/19/1998 AND A RESULT OF 433 MIU/ML WAS GIVEN. THE SAMPLE WAS RETESTED ON 5/20/1998 IN THE DILUTION MODE, GIVING 466 MIU/ML. THE PT HAD A PREVIOUS RESULT OF 650 MIU/ML ON 5/15/1998. THE SPECIMEN WAS SENT TO ANOTHER LAB AND RUN ON THE AXSYM ANALYZER AND A RESULT OF 1727 MIU/ML WAS GIVEN. THE DILATATION AND CURETTAGE WAS THEN CANCELLED. NO REPORT OF INJURY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NA REAGENT, LIST NUMBER 1A06-20.| IMX TOTAL BHCG REAGENT, LIST NUMBER 1A06-20.