CD 22 CONTROLS HALF PACK

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 SELF 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 CALIBRATORS 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.

Description of Event or Problem

THE CUSTOMER REPORTED THE CELL-DYN 22 PLATELET CONTROL LOT 0125 WAS OUT OF RANGE HIGH. THE CUSTOMER ASSAYED A PT SAMPLE WITH CONSISTENT RESULTS AND OPENED A NEW CONTROL AS THE PREVIOUSLY USED CONTROL WAS INADVERTENTLY LEFT OUT OVERNIGHT. THE CONTROL OUT OF RANGE HIGH ISSUE WAS RESOLVED. THE CUSTOMER LATER REQUESTED A VISIT FROM THE ABBOTT FIELD SERVICE REPRESENTATIVE DUE TO INVALID RESULTS FOR CELL-DYN 22 PLATELET CONTROLS AND THE FIELD SERVICE REPRESENTATIVE ADJUSTED THE PLATELET PARAMETER. THE CUSTOMER WAS ALSO SENT A KIT OF CELL-DYN 22 PLATELET CALIBRATORS FOR TROUBLESHOOTING TO DETERMINE IF THE PROBLEM WAS THE LOT OF CELL-DYN 22 CONTROLS OR THE CELL-DYN ANALYZER. THE CUSTOMER PERFORMED TROUBLESHOOTING WITH THE CALIBRATORS AND OBSERVED CONTROLS OUT OF RANGE HIGH. THE CUSTOMER WAS SENT A NEW LOT OF CONTROLS AND THE HIGH AND MEDIUM CONTROL LEVELS WERE ACCEPTABLE. IT IS UNK IF THERE WAS IMPACT TO PT MANAGEMENT.