BEUDAMED
    FDA Adverse Event Other Summary report: N

    ARCHITECT I2000 ANALYZER

    MDR report key: 516388 · Received January 23, 2004

    Report

    Report Number
    1628664-2004-00003
    Event Type
    Other
    Date Received
    January 23, 2004
    Date of Event
    December 22, 2003
    Report Date
    January 20, 2004
    Manufacturer
    ABBOTT MFG, INC.
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER STATES THAT AN INITIAL ARCHITECT BHCG RESULT OF 238.42 IU/L WAS GENERATED ON A PT. THE ACCOUNT HAS A POLICY OF RETESTING ANY BHCG RESULTS THAT FALL WITHIN THE RANGE OF 5 - 1000 IU/L. THE CUSTOMER THEREFORE RETESTED THE SAMPLE AND RESULTS OF 235.53 AND <1.20 IU/L WERE GENERATED. THE CUSTOMER STATES THAT OTHER REPRODUCTIVE HORMONES CONFIRMED LIKELY DIAGNOSIS OF PREGNANCY. THE CUSTOMER REPORTED THE RESULT OF 238.42 IU/L. NO IMPACT TO PT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARCHITECT I2000 ANALYZER AUTOMATED IMMUNOASSAY ANALYZER JJE ABBOTT MFG, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN ARCHITECT BHCG REAGENT LOT NO. 01577M100.