BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CELL-DYN 22 CALIBRATOR

    MDR report key: 907941 · Received September 6, 2007

    Report

    Report Number
    2919069-2007-00136
    Event Type
    Malfunction
    Date Received
    September 6, 2007
    Date of Event
    October 6, 2006
    Report Date
    February 26, 2007
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    KRZ
    PMA / PMN Number
    K902892/A
    Removal / Correction Number
    2919069-9/26/06-003-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    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 MET 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 EXPIRATION 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 · 1

    THE CUSTOMER STATED THE CELL-DYN 3200 SL ANALYZER GENERATED AN ELEVATED PLATELET RESULT AFTER PERFORMING CALIBRATION ON THE INSTRUMENT WITH CELL-DYN 22 CALIBRATOR LOT 3098. THE CUSTOMER ADJUSTED THE PLATELET PARAMETER ON THE INSTRUMENT AND RECALIBRATED. NO PT DATA WAS PROVIDED BY THE CUSTOMER. THERE WAS NO IMPACT TO PT MANAGEMENT REPORTED BY THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CELL-DYN 22 CALIBRATOR CD22 CALIBRATOR KRZ ABBOTT LABORATORIES NA 3098

    Patients

    Seq Age Sex Outcome Treatment
    1 NI YR CELL-DYN 3200 ANALYZER