BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT FSH CALIBRATOR

    MDR report key: 794755 · Received December 4, 2006

    Report

    Report Number
    2623532-2006-00028
    Event Type
    Malfunction
    Date Received
    December 4, 2006
    Date of Event
    September 7, 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
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS THE FINAL REPORT. AN INVESTIGATION IS IN PROCESS.

    Description of Event or Problem · 1

    THIS MEDWATCH IS BEING FILED DUE TO A CUSTOMER COMPLAINT THAT WAS INVESTIGATED. ABBOTT FOUND AN ATYPICAL STABILITY PROFILE FOR THE LOT OF ARCHITECT FSH CALIBRATORS LIST NUMBER 6C24-01 LOT NUMBER 33363Q100. AXSYM FSH MASTER CALIBRATOR LIST NUMBER 7A60-30 LOT NUMBER 33266Q100 AND AXSYM FSH CALIBRATOR LIST NUMBER 9C06-01 WERE MANUFACTURED USING THE SAME BASE MATERIAL AS LOT 33363Q100; THEREFORE, THESE LOTS ARE ALSO IMPACTED. THE INVESTIGATION TO DATE HAS SHOWN THAT BOTH CONTROLS AND PT RESULTS HAVE SHIFTED UPWARDS OVER TIME TOGETHER. A RECALL WAS ISSUED FOR ARCHITECT FSH CALIBRATORS LIST NUMBER 6C24-01 LOT NUMBER 33363Q100, AXSYM FSH MASTER CALIBRATOR LIST NUMBER 7A60-30 LOT NUMBER 33266Q100 AND AXSYM FSH CALIBRATOR LIST NUMBER 9C06-01. THE ISSUE WAS REPORTED UNDER 21 CFR 806 TO THE SAN FRANCISCO FDA DISTRICT OFFICE ON 09/14/2006. ABBOTT HAS NOT REC'D ANY REPORTS OF ADVERSE EVENTS DUE TO THIS ISSUE TO DATE.

    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 NA ARCHITECT I2000 LIST NO. 3M74-01