BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLINICAL CHEMISTRY TOTAL BILIRUBIN

    MDR report key: 1241983 · Received November 25, 2008

    Report

    Report Number
    2018433-2008-00223
    Event Type
    Malfunction
    Date Received
    November 25, 2008
    Date of Event
    November 18, 2008
    Report Date
    November 18, 2008
    Manufacturer
    ABBOTT MANUFACTURING, INC.
    Product Code
    CIG
    PMA / PMN Number
    K060574
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE INVESTIGATION REVIEWED THE CUSTOMER'S PATIENT DATA, THE MANUFACTURING RELEASE DATA FOR TOTAL BILIRUBIN REAGENT LOTS 65088HW00 AND 64048HW00 , AND THE PACKAGE INSERT FOR TOTAL BILIRUBIN ((B)(4)). THE PATIENT RESULTS GENERATED ON (B)(6) 2008 WITH REAGENT LOT 65088HW00 AND CALIBRATOR LOT 63420M100 SHOW LOWER RESULTS THAN WHEN RUN (B)(6) 2008 WITH REAGENT LOT 64048HW00 AND CALIBRATOR LOT 61388M100. THE SAMPLES WERE REFRIGERATED BEFORE BEING RERUN, HOWEVER NO INFORMATION WAS AVAILABLE IF THESE SAMPLES WERE STORED PROTECTED FROM LIGHT. THE LOT RELEASE DATA FOR BOTH REAGENT LOTS SHOWED THAT BOTH LOTS WERE RELEASED USING THE SAME CALIBRATOR LOT AND NO DIFFERENCE IN QUALITY CONTROL SAMPLE RECOVERIES WAS OBSERVED. THE PACKAGE INSERT REVIEW SHOWS THAT SPECIMENS SHOULD BE PROTECTED FROM BRIGHT LIGHT AND ARE GOOD REFRIGERATED UP TO 7 DAYS WHEN PROTECTED FROM LIGHT. THE INVESTIGATION DEMONSTRATED THAT THE CLINICAL CHEMISTRY TOTAL BILIRUBIN ASSAY IS PERFORMING WITHIN ITS INTENDED USE, LABEL CLAIMS AND SPECIFICATIONS. NO DEFICIENCY RELATED TO THE PERFORMANCE OF THE DEVICE WAS IDENTIFIED. THIS IS A FINAL REPORT.

    Additional Manufacturer Narrative · 1

    CLINICAL CHEMISTRY BILIRUBIN CALIBRATOR LOT#: 63420M100; CLINICAL CHEMISTRY BILIRUBIN CALIBRATOR LOT#: 61388M100; CLINICAL CHEMISTRY TOTAL BILIRUBIN ASAY LOT#: 64048HW00. THIS IS AN INITIAL REPORT. AN INVESTIGATION IS IN PROCESS. A FINAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    THE CUSTOMER IS PERFORMING TOTAL BILIRUBIN REAGENT LOT TO LOT CORRELATIONS WITH THE FOLLOWING RESULTS: PATIENT C= 0.3 MG/DL FOR THE ABOVE RESULT, THE CUSTOMER IS USING TOTAL BILIRUBIN ASSAY LOT64048HW00 AND CLINICAL CHEMISTRY BILIRUBIN CALIBRATOR LOT 61388M100. THIS RESULT WAS REPORTED FROM THE LAB. THE RETEST RESULT PATIENT C= 0.1 MG/DL. FOR THIS RESULT, THE CUSTOMER IS USING TOTAL BILIRUBIN LOT65088HW00 AND CLINICAL CHEMISTRY BILIRUBIN CALIBRATOR LOT 63420M100. THIS RESULT WAS NOT REPORTED FROM THE LAB. CONTROLS HAVE NOT SHOWN ANY DIFFERENCES IN THIS STUDY BETWEEN THE TWO COMBINATIONS ABOVE. THE ABBOTT CUSTOMER TECHNICAL ADVOCATE IS TO SEND THE CUSTOMER AN ALTERNATE LOT OF REAGENT FOR TROUBLESHOOTING. THE CUSTOMER STATES THAT THE SAMPLES IN USE ARE FROM 2008, AND HAVE BEEN STORED IN THE REFRIGERATOR. THERE IS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLINICAL CHEMISTRY TOTAL BILIRUBIN FOR THE QUANTITATION OF TOTAL BILIRUBIN IN HUMAN SERUM OR PLASMA CIG ABBOTT MANUFACTURING, INC. 65088HW00

    Patients

    Seq Age Sex Outcome Treatment
    1 ARC C8000 LN:1G06-01 (B)(4)| ARC C8000 LN:1G06-01 (B)(4)