BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLINICAL CHEMISTRY AST-ACTIVATED

    MDR report key: 967378 · Received May 11, 2007

    Report

    Report Number
    2018433-2007-00020
    Event Type
    Malfunction
    Date Received
    May 11, 2007
    Date of Event
    March 26, 2007
    Report Date
    May 7, 2007
    Manufacturer
    ABBOTT LABORATORIES, INC.
    Product Code
    CIT
    PMA / PMN Number
    k981843
    Removal / Correction Number
    2018433-4/13/07-002-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    UNKNOWN

    Narratives

    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.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT THE ASPARTATE AMINOTRANSFERASE ACTIVATED (ASTA) REAGENT IS MISLABELED. THE CUSTOMER STATES THAT ON THE BOX AND ON THE SIDE OF THE REAGENT IT READS AST-A BUT ON THE TOP OF THE BOTTLE IT READS ALTA. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLINICAL CHEMISTRY AST-ACTIVATED QUANTITATION OF ASPARTATE AMINOTRANSFERASE CIT ABBOTT LABORATORIES, INC. NA 46059HW00

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO ARCHITECT C8000 ANALYZER LIST# 01G06-01