BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLINICAL CHEMISTRY IRON

    MDR report key: 1159468 · Received September 11, 2008

    Report

    Report Number
    2018433-2008-00182
    Event Type
    Malfunction
    Date Received
    September 11, 2008
    Date of Event
    September 5, 2008
    Report Date
    September 5, 2008
    Manufacturer
    ABBOTT MANUFACTURING, INC.
    Product Code
    CFM
    PMA / PMN Number
    K981581
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CLINICAL CHEMISTRY IRON FOR THE QUANTITATION OF IRON IN HUMAN SERUM. THE CUSTOMER LOST THE PATIENT SAMPLES IN QUESTION AND THEREFORE, NO SAMPLES WERE AVAILABLE FOR THIS INVESTIGATION FROM THE CUSTOMER SITE. LOT RELEASE DATA CONTAINED IN THE CERTIFICATE OF ANALYSIS FOR IRON REAGENT LOT 60030HW00 DID NOT INDICATE ANY ISSUE WITH PERFORMANCE. DUE TO LACK OF PATIENT SAMPLES, TESTING WAS NOT PERFORMED TO EITHER CONFIRM OR REFUTE THE ALLEGED COMPLAINT ISSUE. NO PRODUCT DEFICIENCY CAN BE DETERMINED WITH THE CLINICAL CHEMISTRY IRON REAGENT. COLLEGE OF AMERICAN PATHOLOGISTS PARTICIPANT SUMMARY EXCERPTS, FROM THE 2007 CHEMISTRY SURVEY CZ-C, SHOW THE VARIOUS METHODOLOGIES UTILIZED BY THE OLYMPUS INSTRUMENTS. CLINICAL CHEMISTRY IRON USES A DIFFERENT METHODOLOGY WHICH IS FERENE WITHOUT PPR AND PRODUCED LOWER RESULTS THAN THE METHODOLOGIES UTILIZED BY THE OLYMPUS INSTRUMENTS. THE OLYMPUS REAGENT LISTS SERUM AND HEPARINIZED PLASMA AS SUITABLE SPECIMENS WHILE CLINICAL CHEMISTRY IRON LISTS ONLY SERUM AS THE REQUIRED SPECIMEN TYPE. RESULTS SEEN BY THE CUSTOMER ARE CONSISTENT WITH PLASMA SAMPLES RATHER THAN SERUM. THE SPECIMENS MAY HAVE BEEN DRAWN FROM A HEPARIN LINE THAT WAS INSUFFICIENTLY CLEARED OF HEPARIN OR THE PATIENT MAY BE ON ANTICOAGULANT THERAPY. A REVIEW OF COMPLAINTS FOUND NO ISSUES REQUIRING FURTHER INVESTIGATION. THE CLINICAL CHEMISTRY IRON PACKAGE INSERT, COMMODITY # (B)(4), (B)(6) 2008 CONTAINS ADEQUATE INFORMATION TO ADDRESS THIS CUSTOMER'S ISSUE. SERUM IS LISTED AS THE ONLY REQUIRED SPECIMEN TYPE. THE INVESTIGATION DEMONSTRATED THAT THE CLINICAL CHEMISTRY IRON ASSAY IS PERFORMING WITHIN ITS INTENDED USE, LABEL CLAIMS AND SPECIFICATIONS. NO DEFICIENCY RELATED TO THE PERFORMANCE OF THE DEVICE WAS IDENTIFIED. THIS IS A FINAL REPORT.

    Additional Manufacturer Narrative · 1

    THIS IS AN INITIAL 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 A YOUNG FEMALE PATIENT TAKING ESTROGEN GENERATED AN ARCHITECT C8000 IRON ASSAY RESULT OF LESS THAN 6.0 UG/DL. THE RESULT WAS REPORTED FROM THE LAB. THE SAMPLE RETESTED WITH THE SAME RESULT. THE SAMPLE WAS THEN TESTED ON A COMPETITOR'S PLATFORM AND GENERATED A RESULT OF 60 UG/DL. CONTROLS HAVE REMAINED WITHIN SPECIFICATIONS. THERE IS NO FURTHER INFORMATION PROVIDED AS TO ANY IMPACT TO PATIENT MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLINICAL CHEMISTRY IRON FOR THE QUANTITATION OF IRON IN HUMAN SERUM CFM ABBOTT MANUFACTURING, INC. NA 60030HW00

    Patients

    Seq Age Sex Outcome Treatment
    1 NI ARCHITECT C8000 ANALYZER LN: 1G06-01, (B)(4)| ARCHITECT C8000 ANALYZER LN: 1G06-01 (B)(4)