CELL-DYN 22 TRI-LEVEL CONTROL

Description of Event or Problem

THE CUSTOMER STATED CELL-DYN 22 PLATELET CONTROL LOT 0125 WERE OUT OF RANGE HIGH FOR THE MEDIUM AND HIGH CONTROL LEVELS. THE CUSTOMER REPORTED THAT THE BACKGROUND FOR THE ASSAY WAS ACCEPTABLE HOWEVER THE BASELINE WAS ELEVATED AND THE CUSTOMER WAS ADVISED TO REPLACE THE MILLIPORE FILTER. THE CUSTOMER FURTHER STATED PT RESULTS WERE ACCEPTABLE HOWEVER, NEW CONTROLS WERE SENT TO THE CUSTOMER AS THE INCREASE/SHIFT IN CONTROL VALUES WAS DUE TO AGING. THE CUSTOMER REPORTED THAT THE NEW LOT OF CELL-DYN 22 PLATELET CONTROLS WAS ACCEPTABLE. IT IS UNK IF THERE WAS IMPACT TO PT MANAGEMENT.

Additional Manufacturer Narrative

PLATELET RECOVERY VALUES WERE OUT OF RANGE HIGH DURING STABILITY TESTING FOR THE CELL-DYN 22 CALIBRATORS, LOTS 3099. 3098, AND 3100 AND CELL-DYN 22 CONTROL LOT 0125 FOR THE CD3200 AND/OR CD RUBY OPTICAL ANALYZERS. CELL-DYN 22 CALIBRATOR LOT 3098 DID NOT MEET SHELF LIFE STABILITY ON THE CELL-DYN 3200 ANALYZER AT ITS EXPIRY. CELL-DYN 22 CALIBRATOR LOT 3099 DID NOT MEET SHELF LIFE STABILITY AND THE 7 DAY OPEN VIAL STABILITY FOR THE PLATELET PARAMETER ON THE CELL-DYN RUBY ANALYZER. INTERNAL DATA INDICATED THAT CELL-DYN 22 CALIBRATOR LOT 3100 WAS EXPERIENCING THE SAME ISSUES AS IT APPROACHED THE OCTOBER 6, 2006 EXPIRY DATE. CELL-DYN 22 CALIBRATORS AND CONTROLS ARE SUBJECTED TO STABILITY TESTING PER ABBOTT DEPARTMENT OPERATING PROCEDURES. THE CELL-DYN 22 CALIBRATORS AND CONTROLS CLAIM PRODUCT SHELF LIFE AND CONSECUTIVE DAY OPEN CONTAINER STABILITY. THE CALIBRATOR AND CONTROL VALUES MUST MEET THE REQUIREMENT WITHIN THE PUBLISHED ASSAY VALUES AND RANGES PER ABBOTT STABILITY TESTING PARAMETERS. THE VALUES RECOVERED DURING STABILITY TESTING ARE THE SAME AS PRODUCT RELEASE VALUES. AN INVESTIGATION WAS PERFORMED AND PROBABLE CAUSES WERE FOUND TO BE A COMBINATION OF THE FOLLOWING ISSUES: COMMON CAUSE PROCESS VARIABILITY OF THE RED BLOOD CELL FRAGMENTATION TO PLATELET LIKE PARTICLES AFFECTING MEAN PLATELET VOLUME, AND SPECIAL CAUSE VARIATION OF TIGHTENING THE PLATELET SPECIFICATION BY 50%. IT WAS DETERMINED THAT RED BLOOD CELL FRAGMENTATION IS ENHANCED BY MECHANICAL STRESS. THESE ISSUES DID NOT ADEQUATELY PREDICT AN INCREASE OF PLATELET COUNT THROUGH THE ESTABLISHED STABILITY CLAIMS. THE FORMULATION AND MANUFACTURING PROCESS USED IN THE MANUFACTURING AND TESTING OF THE CELL-DYN 22 CALIBRATOR AND CONTROLS ARE SPECIFIC TO BOTH THE CALIBRATORS AND CONTROLS AND DOES NOT IMPACT THE OTHER INSTRUMENT PLATFORMS, THEREFORE THE IDENTIFIED PROBABLE CAUSE IS PRODUCT SPECIFIC. THE CORRECTIVE ACTION FOR THE CELL-DYN 22 CALIBRATORS AND CONTROLS IS TO RE-EVALUATE THE PLATELET SPECIFICATION, IMPROVE ASSAY ASSIGNMENT PROCEDURE FOR PLATELET PARAMETER, RE-VALIDATE THE PLATELET MANUFACTURING PROCESS TO INCREASE THE MEAN PLATELET VOLUME AND CONDUCT MONTHLY VALUE ASSIGNMENT. THIS IS THE FINAL REPORT.