BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLINICAL CHEMISTRY BILIRUBIN CALIBRATOR

    MDR report key: 1203491 · Received October 17, 2008

    Report

    Report Number
    2018433-2008-00194
    Event Type
    Malfunction
    Date Received
    October 17, 2008
    Date of Event
    September 19, 2008
    Report Date
    September 19, 2008
    Manufacturer
    ABBOTT MANUFACTURING INC
    Product Code
    JFM
    PMA / PMN Number
    K981706
    Removal / Correction Number
    2018433-09/19/08-004-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ABBOTT CUSTOMERS REPORTED THE FOLLOWING ISSUES FOR CLINICAL CHEMISTRY BILIRUBIN CALIBRATOR: LOW BIAS FOR TOTAL BILIRUBIN QUALITY CONTROL (QC) AND PT RESULTS WITH BILIRUBIN CALIBRATOR LOT NUMBER CHANGE AND RESULTS TRENDING LOW WITH PROFICIENCY SURVEY SAMPLES. INVESTIGATION OF THESE ISSUES DETERMINED THAT THE CALIBRATOR VALUES ASSIGNED TO THE TOTAL BILIRUBIN REAGENT (LIST 6L45 AND 8G62) CAUSED RESULTS TO TREND DOWNWARD OVER THE PAST SEVERAL CALIBRATOR LOT NUMBERS. ON 08/10/2007 A PRODUCT CORRECTION LETTER (FA10AUG2007) WAS ISSUED TO ADDRESS BILIRUBIN LOW RECOVERY COMPLAINTS AND PROVIDED CUSTOMERS WITH NEW BILIRUBIN VALUES FOR ALL ON-MARKET CALIBRATOR LOTS. THE NEW BILIRUBIN VALUES WERE ASSIGNED USING THE SECONDARY STANDARD (B)(6). (B)(6) STANDARD PREPARATION WAS IDENTIFIED AS A SOURCE OF VARIABILITY. THE (B)(6) STANDARD MINIMIZED LOT-TO-LOT VARIABILITY IN THE VALUE ASSIGNMENT PROCESS. FOLLOWING THE USE OF (B)(6) AS A STANDARD FOR THE ASSIGNMENT FOR THE BILIRUBIN CALIBRATOR, AN INCREASE IN CUSTOMER COMPLAINTS FOR HIGH RESULTS FOR TOTAL BILIRUBIN REAGENTS (06L45 AND 08G62) WAS OBSERVED: HIGHER THAN EXPECTED RESULTS ON PROFICIENCY SURVEY SAMPLES, HIGHER THAN EXPECTED QUALITY CONTROL (QC) RECOVERY, AND HIGHER THAN EXPECTED PT RESULTS. AN INVESTIGATION WAS INITIATED FOR THE TOTAL BILIRUBIN REAGENTS. THE ROOT CAUSE WAS DETERMINED TO BE MATRIX ISSUES FOR TOTAL BILIRUBIN REAGENT (DIAZO) RELATED TO THE COMMUTABILITY OF VARIOUS SAMPLES ((B)(6) STANDARD, (B)(6) STANDARD, BILIRUBIN CALIBRATOR, AND PT SAMPLES) DUE TO THE PRODUCTION MATERIALS USED, E.G. HUMAN SERUM ALBUMIN (HSA) VS. BOVINE SERUM ALBUMIN (BSA). THIS MATRIX EFFECT WAS RESPONSIBLE FOR THE OVER-RECOVERY OBSERVED BY CUSTOMERS DURING THE CONVERSION TO THE (B)(6) STANDARD. THE CAUSE OF THIS ISSUE WAS CONFIRMED THROUGH TESTING PERFORMED USING AN EXTERNAL REFERENCE JENDRASSIC AND GROFF METHOD. AS A CORRECTIVE/PREVENTIVE MEASURE ALL ON-MARKET BILIRUBIN CALIBRATOR LOTS WERE RE-VALUE ASSIGNED PER THE NEW VALUE ASSIGNMENT PROCEDURE PROVIDING IMPROVED ACCURACY FOR TOTAL BILIRUBIN REAGENTS. THESE VALUES WERE COMMUNICATED IN THE CUSTOMER LETTER THAT WAS ISSUED ON 09/17/2008 (FA12SEP2008 REVISION 01). IN ADDITION, ABBOTT (B)(4) HAS RE-WRITTEN AND VALIDATED THE PROCEDURE FOR BILIRUBIN CALIBRATOR. VALUE ASSIGNMENT AND VALUE VERIFICATION THAT INCLUDE: CLARIFIED PROCEDURE FOR PRIMARY (B)(6) STANDARD PREPARATION AND INCREASING REPLICATES TO IMPROVING ACCURACY; REVALIDATED THE PROCEDURE. REASSIGNED OF (B)(6) STANDARDS USING IN-HOUSE PREPARED (B)(6) STANDARD TO ALLOW FOR LESS VARIABILITY FROM ONE ASSIGNMENT TO ANOTHER. ASSIGNED THE VALUES FOR BILIRUBIN CALIBRATOR USING REASSIGNED (B)(6) STANDARDS BY IN-HOUSE PREPARED (B)(6) STANDARDS PER JENDRASSIC AND GROFF METHOD. THIS IS THE FINAL REPORT.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT A LARGE BIAS (22%) OF BILIRUBIN RESULTS WAS OBSERVED FOR PT RESULTS GENERATED ON THE ARCHITECT C8000 ANALYZER. THE CUSTOMER PULLED 442 SAMPLES TO RERUN THE TESTS, 80 PT RESULTS WERE CHANGED AFTER THEY WERE ORIGINALLY REPORTED OUT AS ABNORMAL. IMPACT TO PT MANAGEMENT IS UNK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLINICAL CHEMISTRY BILIRUBIN CALIBRATOR FOR THE CALIBRATION OF CC BILI JFM ABBOTT MANUFACTURING INC 57919M100

    Patients

    Seq Age Sex Outcome Treatment
    1 ARCHITECT C8000 PRC MOD: 1G06-01| CC TOTAL BILIRUBIN REAGENT: LIST # 6L45-20