BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AXSYM FSH CALIBRATOR

    MDR report key: 793663 · Received December 1, 2006

    Report

    Report Number
    2623532-2006-00024
    Event Type
    Malfunction
    Date Received
    December 1, 2006
    Date of Event
    October 5, 2006
    Report Date
    October 13, 2006
    Manufacturer
    ABBOTT DIAGNOSTICS INTERNATIONAL, LTD.
    Product Code
    CGJ
    PMA / PMN Number
    K935612
    Removal / Correction Number
    Z-0024-2007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOWING A CUSTOMER COMPLAINT, ABBOTT FOUND AN ATYPICAL STABILITY PROFILE OF ARCHITECT FSH CALIBRATOR LOT 33363Q100. AXSYM FSH CALIBRATOR LOT 33362Q100 WAS MFG USING THE SAME BASE MATERIAL AS LOT 33363Q100; THEREFORE, THIS LOT IS ALSO IMPACTED. 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 QC (BIORAD) HAS BEEN RUNNING HIGH OUT OF RANGE FOR THE AXSYM FSH ASSAY. NO SUSPECT RESULTS WERE GENERATED OR REPORTED OUT OF THE LAB. NO IMPACT TO PT MGMT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AXSYM FSH CALIBRATOR MEIA FOR THE QUANTITATIVE DETERMINATION OF FSH IN HUMAN SERU CGJ ABBOTT DIAGNOSTICS INTERNATIONAL, LTD. NA 33362Q100

    Patients

    Seq Age Sex Outcome Treatment
    1 NA AXSYM FSH REAGENT LOT NO. 43065Q100| AXSYM ANALYZER LIST NO. 7A83-01