BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLINICAL CHEMISTRY AST-ACTIVATED

    MDR report key: 958407 · Received April 26, 2007

    Report

    Report Number
    2018433-2007-00004
    Event Type
    Malfunction
    Date Received
    April 26, 2007
    Date of Event
    April 4, 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
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS A FINAL REPORT.

    Description of Event or Problem · 1

    TO DATE SEVEN CUSTOMER COMPLAINTS (INTERNATIONAL AND OTHER COUNTRY) WERE RECIEVED FOR AST-ACTIVATED REAGENT (LIST 08D37-30; LOT 46059HW00) WITH REAGENT CARTRIDGES CONTAINING AN INCORRECT TOP LABEL WITH THE PRODUCT SHORT-NAME ALTA INSTEAD OF ASTA. CUSTOMER MAY FIND AN AST ACITVATED REAGENT CARTRIDGE WITH AN INCORRECT TOP LABEL WITH THE PRODUCT SHORT-NAME ALTA INSTEAD OF ASTA. TWO SCENARIOS MAY OCCUR WHEN A CUSTOMER ENCOUNTERS THIS CARTRIDGE LABELING ISSUE: IN SCENARIO # 1- THE CUSTOMER RUNS ASSAY USING REAGENT BARCODE LABEL AS ASTA. NO IMPACT ON RESULTS. IN SCENARIO # 2- THE CUSTOMER MISTAKENLY RUNS ALTA REAGENT IN THIS ASTA CARTRIDGE. RESULTS OBTAINED MAY BE HIGH OR LOW AND REPORTED AS ASTA NOT REPORTED AS ALTA. A RECALL WAS ISSUED AND REPORTED TO THE FDA. ABBOTT HAS NOT RECIEVED ANY REPORTS OF ADVERSE EVENTS RELATED TO THIS ISSUE.

    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