TECHNICAL UPDATE Miami Technical Support Number: TU2002M143 Date: Subject: COULTER Ac•T 5diff Cap Pierce – Cap Pierce Door Failure and Potential for Incorrect Sample Results with Patient Information. January 30, 2003 Beckman Coulter Inc. has identified a condition on the Ac•T 5diff Cap Pierce that may result in the association of incorrect sample results with patient demographic information. This situation occurs when the cap pierce door on the Ac•T 5diff Cap Pierce fails to open after each cycle. If the door remains closed and does not open, the tube in the holder may be sampled multiple times. The following scenarios may occur: • If the instrument is configured with auto numbering ON, the instrument will cycle until the cap pierce door opens or until there is an analyzer error that stops the instrument. • If there are multiple worklist entries, the system will cycle until all patient demographic information entries on the worklist have been associated with results, the cap pierce door opens or there is an analyzer error that stops the instrument. The circumstances that prevent the cap pierce door from automatically opening include: • Failure of the tube holder open solenoid. • Incorrect tube size resulting in restriction of the tube holder movement. • Multiple labels on sample tubes restricting movement. • Misalignment of the tube holder door cover plate. To prevent this situation from occurring, it is imperative that the instrument be monitored for the automatic opening of the cap pierce door after each cycle. Please reinforce the importance of confirming patient demographic and Sample ID information prior to sample analysis. Reference Chapter 8, Sample Analysis. Attached to this Technical Update is a copy of the customer letter distributed to all Ac•T 5diff Cap Pierce customers. Customers may delete the database to prevent the reporting of incorrectly associated sample results as no editing or deletion function is available with this software. Should customers require assistance with sample results associated with the wrong patient information they should contact the Beckman Coulter Technical Support Center at 1-800-256-7674 in the United States and Canada or for International customers, their local Beckman Coulter Representative. Please review the information contained in the letter and this update. If you have any concerns regarding this information, please contact Technical Support. CONFIDENTIAL Reproduction without written permission of Beckman Coulter Incorporated is prohibited. 1 …Still Counting® MTS41601B