BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CC IRON/MAGNESIUM CALIBRATOR

    MDR report key: 1052458 · Received May 22, 2008

    Report

    Report Number
    2018433-2008-00104
    Event Type
    Malfunction
    Date Received
    May 22, 2008
    Date of Event
    March 20, 2008
    Report Date
    April 28, 2008
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    JIX
    PMA / PMN Number
    K981706
    Removal / Correction Number
    2018433-05/05/08-002-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, 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 BY THE OEM 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 AFTER BEGINNING A NEW LOT OF IRON/MAGNESIUM CALIBRATORS ON THE ARCHITECT C8000 ANALYZER, THE QUALITY CONTROL FOR BOTH SERUM AND URINE, AND THE PT RESULTS SHIFTED DOWN. THE CUSTOMER ALSO NOTED THE INSTRUMENT WAS RUNNING FINE WITH THE PREVIOUS LOT. THE CUSTOMER PULLED FOUR PREVIOUSLY RUN SAMPLES FOR COMPARISON. ALL FOUR SAMPLE RESULTS SHIFTED DOWN WITH THE NEW CALIBRATOR. SAMPLE FOUR OF FOUR HAD AN ORIGINAL RESULT OF 1.8 MEQ/L AND A REPEAT RESULT OF 1.5 MEQ/L. THE ORIGINAL RESULT WAS REPORTED. ALL INSTRUMENT MAINTENANCE IS UP TO DATE. THERE ARE NO KNOWN INSTRUMENT ISSUES OR RECENT PART CHANGES. THE ABBOTT CUSTOMER TECHNICAL ADVOCATE SENT THE CUSTOMER AN ALTERNATE CALIBRATOR LOT FOR TROUBLESHOOTING. A FOLLOW-UP WITH THE CUSTOMER CONFIRMED RECEIPT OF THE NEW LOT OF CALIBRATOR. THE CUSTOMER RECALIBRATED THE INSTRUMENT AND ALL OF THE QUALITY CONTROL RECOVERED 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 JIX ABBOTT LABORATORIES NA 54187M200

    Patients

    Seq Age Sex Outcome Treatment
    1 NI ARCHITECT C8000