BEUDAMED
    FDA Adverse Event Other Summary report: N

    CLINICAL CHEMISTRY PHENYTOIN

    MDR report key: 938887 · Received November 8, 2007

    Report

    Report Number
    2018433-2007-00233
    Event Type
    Other
    Date Received
    November 8, 2007
    Date of Event
    October 10, 2007
    Report Date
    October 15, 2007
    Manufacturer
    ABBOTT MANUFACTURING, INC.
    Product Code
    LES
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS AN INITIAL REPORT. A FINAL REPORT WILL BE SUBMITTED AT THE CONCLUSION OF AN INVESTIGATION.

    Description of Event or Problem · 1

    THE CUSTOMER STATES, THAT FALSELY ELEVATED RESULTS WERE GENERATED FOR ONE PATIENT SAMPLE USING ARCHITECT C8000 PHENYTOIN ASSAY. NO SUSPECT RESULTS WERE REPORTED FROM THE LAB. THE CUSTOMER STATES, THAT IN 2007, AT 15:58 HRS, THE SAMPLE FROM THIS PATIENT READ 72, 81, AND 106 UMOL/L. AT 17:20 HRS, THE SAMPLE READ 69, 69, 69, 67 AND 67 UMOL/L. AT 22:36 HRS, THE SAMPLE READ 77, 79, 77, 78, AND 80 UMOL/L. THE FOLLOWING DAY, THE PATIENT GENERATED A RESULT OF 72 UMOL/L. AT 09:27 HRS A RESULT OF 95 UMOL/L WAS GENERATED. AT 11:57 HRS, ONE SAMPLE GENERATED RESULTS OF 77, 81, 79 AND 95 UMOL/L. THE CUSTOMER STATES, THAT THE PHENYTOIN ASSAY IS THE ONLY ASSAY WITH THIS PRECISION ISSUE. CONTROLS HAVE REMAINED WITHIN SPECIFICATIONS. THERE IS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLINICAL CHEMISTRY PHENYTOIN QUANTITATION OF PHENYTOIN IN HUMAN SERUM OR PLASMA LES ABBOTT MANUFACTURING, INC. NA 52013HW00

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK YR Other ARCHITECT C8000 ANALYZER LIST#: 1G06-01