BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMX ANALYZER

    MDR report key: 274515 · Received April 21, 2000

    Report

    Report Number
    1628664-2000-00024
    Event Type
    Injury
    Date Received
    April 21, 2000
    Date of Event
    March 16, 2000
    Report Date
    April 19, 2000
    Manufacturer
    ABBOTT MFG, INC.
    Product Code
    LCI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE PT SAMPLE WAS RUN ON THE 1:200 DILUTION PROTOCOL AND RECEIVED RESULTS OF 8704/11912/12788 MIU/ML. SAMPLE SENT TO ANOTHER LAB AND RUN ON THE AXSYM AND GOT RESULTS OF 27233 MIU/ML. CUSTOMER HAD REPORTED THE PREVIOUS RESULTS. THE PHYSICIAN WAS MONITORING PT FOR SIGNS OF THREATENED ABORTION SINCE PT HAD INTERMITTENT BLEEDING. THE INCORRECT RESULT OF 12350 MIU/ML CONFIRMED PHYSICIAN'S SUSPICION ABOUT PT'S MISCARRYING THE EMBRYO AND A DILATATION AND CURETTAGE WAS PERFORMED. ACCOUNT DID NOT HAVE ANY INFO REGARDING PT INFO, INCLUDING PREVIOUS BETA-HUMAN CHORIONIC GONADOTROPIN RESULTS OR CURRENT CONDITION. THERE IS NO INFO STATING WHETHER FETUS WAS VIABLE AT THE TIME THE DILATATION AND CURETTAGE WAS PERFORMED.

    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 NO INFO Other IMX HCG REAGENT