BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLINICAL CHEMISTRY BILIRUBIN CALIBRATOR

    MDR report key: 1203487 · Received October 17, 2008

    Report

    Report Number
    2018433-2008-00192
    Event Type
    Malfunction
    Date Received
    October 17, 2008
    Date of Event
    September 18, 2008
    Report Date
    September 18, 2008
    Manufacturer
    ABBOTT MFG, INC.
    Product Code
    JIX
    PMA / PMN Number
    K981706
    Removal / Correction Number
    2018433-09/19/08-004-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    EXPLANATION OF OTHER CONCLUSION: ABBOTT CLINICAL CHEMISTRY BILIRUBIN CALIBRATOR - VALUE ASSIGNMENT PROCESS WAS INADEQUATE CAUSING LOW AND HIGH RESULTS ON PT SAMPLES AND (B)(6) SURVEYS. ABBOTT CLINICAL CHEMISTRY BILIRUBIN CALIBRATOR IS USED ON THE AEROSET AND ARCHITECT CSYSTEM TO CALIBRATE TOTAL AND DIRECT BILIRUBIN. 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. 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. WITH A CHANGE FROM CALIBRATOR LOT 38436M100 TO LOT 41456M100 A BIAS OF (-) 7% TO 3% WAS OBSERVED. WITH A CHANGE FROM CALIBRATOR LOT 38436M100 TO LOT 42396M100 A BIAS OF (-) 4% TO 2% WAS OBSERVED. WITH A CHANGE FROM CALIBRATOR LOT 38436M100 TO LOT 48616M100 A BIAS OF (-) 5.5% TO 3.2% WAS OBSERVED. 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 RESULTS REPORTED ON A (B)(6) SURVEY SAMPLE FOR NEONATAL BILIRUBIN WERE HIGHER THAN THE EXPECTED RESULTS. QC WAS WITHIN RANGE AT THE TIME OF THE SURVEY AND ALL MAINTENANCE WAS UP TO DATE. NO IMPACT TO PT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLINICAL CHEMISTRY BILIRUBIN CALIBRATOR FOR USE IN THE CALIBRATION OF CC BILI JIX ABBOTT MFG, INC. NA 54754M100

    Patients

    Seq Age Sex Outcome Treatment
    1 LOT# 59074HW00| ARCHITECT C8000: LIST# 1G06-01, SERIAL# (B)(4)| CC TOTAL BILIRUBIN REAGENT: LIST# 6L45-40,