BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT FSH CALIBRATOR

    MDR report key: 793635 · Received December 1, 2006

    Report

    Report Number
    2623532-2006-00025
    Event Type
    Malfunction
    Date Received
    December 1, 2006
    Date of Event
    July 24, 2006
    Report Date
    August 31, 2006
    Manufacturer
    ABBOTT DIAGNOSTICS INTERNATIONAL, LTD.
    Product Code
    CGJ
    PMA / PMN Number
    K032458
    Removal / Correction Number
    Z-0024-2007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOWING A CUSTOMER COMPLAINT, ABBOTT FOUND AN ATYPICAL STABILITY PROFILE OF ARCHITECT FSH CALIBRATOR LOT 33363Q100. THE INVESTIGATION TO DATE HAS SHOWN THAT BOTH CONTROLS AND PT RESULTS HAVE SHIFTED UPWARDS TOGETHER OVER TIME. THERE HAS BEEN NO ADVERSE EVENTS ASSOCIATED WITH THIS ISSUE TO DATE. THIS IS AN INTIAL REPORT. AN INVESTIGATION IS IN PROCESS. A FINAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    THE CUSTOMER STATES THAT THEY NOTICED A SHIFT UP IN CONTROLS (BIORAD) AND PT RESULTS WHEN USING THE ARCHITECT FSR ASSAY WITH ARCHITECT FSH CALIBRATORS LOT NUMBER 33363Q1. PT RESULTS WERE REPORTED OUT OF THE LAB WITH QC OUT OF RANGE. NO IMPACT TO PT MGMT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARCHITECT FSH CALIBRATOR CMIA FOR THE QUANTITATIVE DETERMINATION OF FSH IN HUMAN SERU CGJ ABBOTT DIAGNOSTICS INTERNATIONAL, LTD. NA 33363Q100

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN ARCHITECT I2000 LIST NO. 8C89-01