BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CC IRON/MAGNESIUM CALIBRATOR

    MDR report key: 1052455 · Received May 22, 2008

    Report

    Report Number
    2018433-2008-00108
    Event Type
    Malfunction
    Date Received
    May 22, 2008
    Date of Event
    February 21, 2008
    Report Date
    April 28, 2008
    Manufacturer
    ABBOTT MANUFACTURING, INC.
    Product Code
    JGJ
    PMA / PMN Number
    K981706
    Removal / Correction Number
    2018433-05/05/08-002-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS DETERMINED AFTER COMPLETION OF IN-HOUSE TESTING THAT THE IRON/MAGNESIUM CALIBRATOR LOT 54187M200 VALUE ASSIGNMENT SHEET, WAS INCORRECTLY ASSIGNED WITH A SET POINT FOR CAL 2 AT 3.2 MEQ/L INSTEAD OF 0.8 MEQ/L. AN ASSESSMENT TO PT IMPACT WAS PERFORMED AND VALUES ABOVE 0.8 MEQ/L WERE FOUND TO BE 17.24% LOWER THAN THEY SHOULD BE. THIS IS AN INITIAL REPORT. THE MFR HAS BEEN NOTIFIED AND A FURTHER INVESTIGATION IS CURRENTLY IN PROCESS. A FINAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT THEY STARTED A NEW LOT OF IRON/MAGNESIUM CALIBRATORS ON THE AEROSET ANALYZER AND THE QUALITY CONTROL SHIFTED LOW FOR MAGNESIUM. THE CUSTOMER STATES THEY RERAN FOUR SAMPLES WITH ORIGINAL RESULTS OBTAINED ON THE PREVIOUS CALIBRATOR LOT. SAMPLE FOUR OF FOUR HAD AN ORIGINAL RESULT OF 1.5 MEQ/L AND A REPEAT RESULT OF 1.8 MEQ/L. NO RESULTS WERE QUESTIONED BY THE PHYSICIAN. THE CUSTOMER STATED THAT THE INSTRUMENT MAINTENANCE IS UP TO DATE, AND THERE ARE NO OTHER ASSAY ISSUES. THE ABBOTT CUSTOMER TECHNICAL ADVOCATE SENT A DIFFERENT CALIBRATOR LOT FOR TROUBLESHOOTING. THE CUSTOMER RECEIVED THE NEW CALIBRATOR AND THE QUALITY CONTROL IS BACK IN RANGE. NO IMPACT TO PT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CC IRON/MAGNESIUM CALIBRATOR FOR USE IN THE CALIBRATION OF THE IRON AND MAGNESIUM ASSAYS JGJ ABBOTT MANUFACTURING, INC. NA 54187M200

    Patients

    Seq Age Sex Outcome Treatment
    1 NI AEROSET ANALYZER, LIST# 9D05-01