BEUDAMED
    FDA Adverse Event Other Summary report: N

    IMX ANALYZER

    MDR report key: 269135 · Received March 8, 2000

    Report

    Report Number
    1628664-2000-00013
    Event Type
    Other
    Date Received
    March 8, 2000
    Date of Event
    January 31, 2000
    Report Date
    March 3, 2000
    Manufacturer
    ABBOTT MANUFACTURING, INC.
    Product Code
    LCI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ON 01/31/2000 THE ACCOUNT REPORTED AN IMX B-HCG RESULT OF 93,692 MLU/ML. THE PHYSICIAN QUESTIONED THE RESULT AS AN ULTRASOUND HAD CONFIRMED THAT THE PT HAD AN ECTOPIC PREGNANCY. THE SAMPLE WAS REPEATED AND WAS 1,032 MLU/ML. ACCOUNT STATED THAT PT TREATMENT WAS NOT IMPACTED.

    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 ABBOTT IMX B-HCG REAGENT LIST #1A06-22.