BEUDAMED
    FDA Adverse Event Other Summary report: N

    ARCHITECT TOTAL BHCG

    MDR report key: 654349 · Received December 16, 2005

    Report

    Report Number
    1415939-2005-00030
    Event Type
    Other
    Date Received
    December 16, 2005
    Date of Event
    May 1, 2005
    Report Date
    December 13, 2005
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    DHA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER STATES THAT THE FOLLOWING ARCHITECT TOTAL B-HCG RESULTS WERE GENERATED ON A PT: 2005 - 8,000 MIU/ML, 2005/4 MOS LATER - 173 MIU/ML (CHEMICAL TREATMENT STARTED), 2005/18 DAYS LATER -30 MIU/ML (CHEMICAL TREATMENT STOPPED), 2005/8 DAYS LATER -58 MIU/ML, 2005/7 DAYS LATER 84 -MIU/ML. THE SAME MONTH - 41 MIU/ML(SURGERY PERFORMED - NO DETAILS AVAILABLE), 2005/THE FOLLOWING MONTH -65 MIU/ML. A SAMPLE FROM THE PT WAS TESTED USING AN ALTERNATE BHCG METHOD (RIA) WHICH GENERATED A RESULT OF 0.2 MIU/ML. NO SPECIFIC DETAILS REGARDING PT DIAGNOSIS, CHEMICAL TREATMENT, OR TYPE OF SURGERY WAS AVAILABLE DUE TO PT CONFIDENTIALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARCHITECT TOTAL BHCG IMMUNOASSAY FOR MEASUREMENT OF TOTAL BHCG DHA ABBOTT LABORATORIES NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN