On march 21, 2017, the customer reported suboptimal tissue after processing on their leica asp6025.As a result, some specimens could not be diagnosed and 10 patients are confirmed to require rebiopsies.Attempts were made to obtain the patient identifier information for the 10 patients who were confirmed to require rebiopsy but the customer declined to provide this information.
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The investigation revealed the following: the incident was presumably user related due to a wrong application from the customer site.The customer had used a wrong protocol for the too small biopsies.The logs of the affected instrument were analyzed and no any technical issues were detected.The investigation from application site revealed that the tissues were underprocessed.The provided image from the customer showed that the fatty tissue was still yellow which would indicate that there has been inadequate dehydration and/or clearing, which could lead to underprocessed tissues.Additionally the customer is using sub-x as a xylene substitute.Leica biosystems (b)(4) do not have any validated protocol with sub-x.The customer has to validate the usage of this xylene themselves.Therefore leica biosystems (b)(4) cannot provide nor recommend any protocol along with sub x and (b)(4).If sub x is not exchanged enough it becomes saturated and cannot absorb more.For the same reason leica biosystems (b)(4) do not recommend to use sub x as cleaning xylene because it is not so strong and needs to be changed at least after every 4th runs.A customer facing letter will be sent to the customer with a recommendation in the future of how to properly care for the tissues, reagents and protocols during the processing with the tissue processor.
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