[311935]
Physician has encountered a very serious issue with a dade-behring ptt coagulation reagent, that physician believes is creating a major risk to pt safety in some hospitals using new lots of dade actin-fsl reagent. Actin-fsl is the most commonly used ptt reagent used by over 800 laboratories. Dade made a decision to increase the sensitivity to heparin of this ptt reagent. New lots of the more sensitive reagents were first released in june 2004. Dade did not communicate this change to any customers before the release of this product. The new lots have proven to be much more sensitive to heparin than dade intended, producing a heparin therapeutic range of 70-120 seconds, compared to their current range of 48-75 seconds. Dade intended the new actin-fsl to produce a range of 60-90 seconds, and recognizes that the first lots of the newly formulated reagent are not performing as expected. Most hosp clinical laboratories are not highly sophisticated in coagulation testing, and may adopt the new reagent without changing the heparin therapeutic range. This will put pts at risk for serious thrombotic events -including death from pulmonary embolus or coronary artery thrombosis- because the pts will be under-heparinized when monitored with the unaltered ptt heparin therapeutic range. Their pathologists and lab personnel have already spent hundreds of man-hours on this problem. They have been in touch with several other hosp clinical laboratories that have made the same observations with the dade actin-fsl reagent. One of those hosp laboratories put the new reagent in place without initially recognizing the increased heparin sensitivity, did not change the heparin therapeutic range, and even with dade's technical assistance, did not identify the cause of unexpected high ptt values until two months later. They believe that there are many other hospitals using the new highly sensitive actin-fsl with an unaltered, inappropriately low -for the new sensitive reagent- heparin therapeutic range, and putting pt safety at risk. They have had numerous communications with dade rep, including high-level executives responsible for commercial activities and marketing. They have urged them to 1- reconsider their decision to alter this reagent 2- withdraw the new lots of actin-fsl that are not performing according to mfr's expectations 3- immediately and clearly communicate the changes made to the actin-fsl reagent, and the associated risks to dade's laboratory customers. Dade has informed them that they will no longer mfr actin-fsl with the heparin sensitivity that their laboratory -and 800 other laboratories- expect. Dade told them that they do not plan to recall the initial new lots of actin-fsl that are not performing as dade expected. Finally, dade did issue a customer notification memorandum in september 2004, but this has very limited info, and does not even state that the reagent has been changed to be more sensitive to heparin. Because they now feel that they have done everyghing they can to communicate with dade, and because they feel that dade's response has been inadequate, physician is notifying the fda, with the hope that this issue will be properly investigated, and that the very real risks associated with the new lots of actin-fsl reagent will be clearly communicated to all laboratories using this reagent. Background-the dade action-fsl reagent is used for ptt testing, one of the basic coagulation tests performed in all hosp clinical laboratories. Many different medical specialists use this test, often in critically ill pts. The ptt test is the only method they have to monitor intravenous heparin therapy. It is critically important that the heparinized pts' ptt be within the proper therapeutic range. If the ptt is low, there is risk of thrombosis; if the ptt is high, there is risk of hemorrhage. Physicians use heparin dosing protocols to monitor the pts' ptt and adjust the heparin dose appropriately. The hosp lab establishes the heparin therapeutic range by testing of heparinized plasma samples, and assures that the therapeutic range is stable when no lots of ptt reagent are put into place. Hosp laboratories depend on mfrs for lot-to-lot consistency, and generally do not have to alter heparin therapeutic ranges with new lots of reagent. The dade actin-fsl reagent is the most commonly used ptt reagent from any mfr; it is used by over 800 different laboratories almost all of these are hosp laboratories that do ptt testing to monitor intravenous heparin dosing. The problem they determined in 2004 that dade made changes in the formulation of the actin-fsl reagent that make the reagent markedly more sensitive to heparin than previous lots. The new lots of reagent produce a heparin therapeutic range of approximately 70-120 seconds, compared to their current therapeutic range of 48-75 seconds. They determined the new therapeutic range in their lab using the currently recommended heparin xa vs. Ptt analysis of ex-vivo pt heparinized plasma specimens. They also did parallel testing of heparinized specimens and found marked elevations of ptt with the new reagent compared to their old lot, edpecially at higher levels of heparin. They were very surprised with these findings, since dade made no advance announcement of this change to any laboratory customers. Physician has since been in contact with several other hosp labs that use dade actin-fsl; each has independently observed the same marked increased sensitivity to heparin, confirming their findings. All of the outside laboratories physician contacted share their concerns regarding significant risk to pt safety.
Patient Sequence No: 1, Text Type: D, B5