BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLINICAL CHEMISTRY IRON

    MDR report key: 1171505 · Received September 17, 2008

    Report

    Report Number
    2018433-2008-00185
    Event Type
    Malfunction
    Date Received
    September 17, 2008
    Date of Event
    September 1, 2008
    Report Date
    September 3, 2008
    Manufacturer
    ABBOTT MANUFACTURING, INC.
    Product Code
    CFM
    PMA / PMN Number
    K981581
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    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.

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER WAS COMPLAINING OF IRON REPRODUCIBILITY ISSUES. MAINTENANCE WAS UP TO DATE. CUSTOMER USING CLINICAL CHEMISTRY IRON, LN 7D68-30, EXP 10/30/2008 AND IRON/MG CALIBRATOR, LN 1E69-03, EXP 6/9/2008. IT WAS LATER IDENTIFIED THE CUSTOMER WAS USING EXPIRED CALIBRATORS WHEN THE SUSPECT RESULTS WERE GENERATED. REVIEW THE CLINICAL CHEMISTRY IRON/ MAGNESIUM CALIBRATOR PACKAGE INSERT COMMODITY #(B)(4) WAS PERFORMED. PAGE 1, "WARNINGS AND PRECAUTIONS" SECTION STATES; "DO NOT USE COMPONENTS BEYOND THE EXPIRATION DATE". REVIEW OF THE ABBOTT METRIC REPORTS INDICATED NO SIMILAR COMPLAINTS WERE FOUND. THIS IS THE FINAL REPORT.

    Description of Event or Problem · 1

    THE ACCOUNT STATED THAT THE RESULTS FROM THE ARCHITECT IRON ASSAY ARE NON-REPRODUCIBLE. FOR PATIENT #2, THE INITIAL RESULT= 6 UG/DL, THE SAMPLE WAS THEN TESTED IN DUPLICATE AND BOTH RESULTS WERE 15 UG/DL. THE ACCOUNT STATES THE INITIAL RESULT WHICH IS TOO LOW IS THE INCORRECT RESULT. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    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 IRON/MAG CAL, LIST# 1E69-03, LOT# 57921M100| ARCITECT C8000 ANALYZER, (B)(4)| ARCHITECT C8000 ANALYZER, (B)(4)| ARCHITECT C8000 ANALYZER, (B)(4)