BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABBOTT CLINICAL CHEMISTRY CREATINE KINASE

    MDR report key: 932549 · Received October 24, 2007

    Report

    Report Number
    2018433-2007-00214
    Event Type
    Malfunction
    Date Received
    October 24, 2007
    Date of Event
    August 30, 2007
    Report Date
    September 25, 2007
    Manufacturer
    ABBOTT MANUFACTURING, INC.
    Product Code
    CGS
    PMA / PMN Number
    K983070
    Removal / Correction Number
    2018433-10/15/07-006-R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION HAS DETERMINED THAT SOME CARTRIDGES WITH CK LOT #52044HW00, EXPIRATION OCTOBER 19, 2007, MAY CAUSE DECREASED QC AND/OR PATIENT RESULTS, INCREASED IMPRECISION, AND ERROR CODE 1054 (UNABLE TO CALCULATE RESULT, REACTION CHECK FAILURE) WHEN A CARTRIDGE IS INITIALLY PLACED INTO USE ON THE ARCHITECT CSYSTEMS. AN INVESTIGATION IS IN PROCESS. A FINAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT THE NEW CLINICAL CHEMISTRY CREATINE KINASE REAGENT LOT# 52044HW00 YIELDED QUALITY CONTROL RESULTS OUT OF RANGE LOW. LEVEL 1 WAS 148.1 U/L WITH PREVIOUS LOT, IS NOW 123, 126, AND 124 U/L. LEVEL 2 WAS 454.5 U/L WITH PREVIOUS LOT, IS NOW 376, 377, AND 378 U/L. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ABBOTT CLINICAL CHEMISTRY CREATINE KINASE QUANTITATION OF CREATINE KINASE IN HUMAN SERUM OR PLASMA CGS ABBOTT MANUFACTURING, INC. NA 52044HW00

    Patients

    Seq Age Sex Outcome Treatment
    1 NI YR ARCHITECT C8000