BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT TOTAL B-HCG REAGENT

    MDR report key: 1827343 · Received September 7, 2010

    Report

    Report Number
    1415939-2010-00487
    Event Type
    Malfunction
    Date Received
    September 7, 2010
    Date of Event
    August 17, 2010
    Report Date
    August 17, 2010
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    DHA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, ARCHITECT B-HCG REAGENT, LIST 7K78-26, THAT HAS A SIMILAR US PRODUCT DISTRIBUTED IN THE US, ARCHITECT B-HCG REAGENT, LIST 6C21.A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    THE CUSTOMER STATED AN ARCHITECT I2000SR ANALYZER GENERATED A FALSELY ELEVATED B-HCG RESULT FOR ONE PATIENT SAMPLE. THE SAMPLE GENERATED AN INITIAL B-HCH RESULT OF 4.87 MIU/ML AND REPEAT B-HCG RESULTS OF 1131 MIU/ML. THE FALSELY ELEVATED B-HCG RESULT WAS NOT REPORTED OUTSIDE THE LABORATORY AND THERE WAS NO ADVERSE IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARCHITECT TOTAL B-HCG REAGENT FOR THE DETERMINATION OF BETA-HUMAN CHORIONIC GONADOTROPIN DHA ABBOTT LABORATORIES 81919JN00

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR ARCH I2000SR LN 3M74-01 SN (B)(4)| ARCH I2000SR LN 3M74-01 SN (B)(4)