BEUDAMED
    FDA Adverse Event Other Summary report: N

    ABBOTT CLINICAL CHEMISTRY TOTAL BILIRUBIN

    MDR report key: 926682 · Received October 11, 2007

    Report

    Report Number
    2018433-2007-00157
    Event Type
    Other
    Date Received
    October 11, 2007
    Date of Event
    September 11, 2007
    Report Date
    September 14, 2007
    Manufacturer
    ABBOTT MANUFACTURING, INC.
    Product Code
    JFM
    PMA / PMN Number
    K060574
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    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, INTERMITTENT ERRATIC LOW TOTAL BILIRUBIN PATIENT RESULTS HAVE BEEN GENERATED ON THE ARCHITECT C8000. RESULTS OF <0.1 MG/DL HAVE BEEN REPORTED AND UPON REPEAT ARE 0.1 - 0.6 MG/DL. A DELTA CHECK FLAG WAS GENERATED ON THE <0.1 MG/DL RESULTS WHICH PROMPTED RETESTING. CORRECTED REPORTS WERE ISSUED. THE CUSTOMER DID NOT HAVE SPECIFIC DATA, BUT IDENTIFIED FIVE PATIENTS SAMPLES THAT EXHIBITED ERRATIC RESULTS. THIS REPORT IS FOR PATIENT #2. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ABBOTT CLINICAL CHEMISTRY TOTAL BILIRUBIN QUANTITATION OF TOTAL BILIRUBIN JFM ABBOTT MANUFACTURING, INC. NA 52048HW00

    Patients

    Seq Age Sex Outcome Treatment
    1 NI YR ARCHITECT C8000 ANALYZER LIST #1G06-01