This report was initially submitted following notification from a customer in columbia regarding incorrect staining results in association with the previcolor® gram instrument v2 (ref.414292, serial number (b)(6)) while staining patient urine samples.Local customer service visited the customer and fixed the issue.The staining issue was fixed by increasing the volume of urine from 10 ¿l to 40 ¿l.There are no specifications regarding the volume of urine to put on the previcolor® gram slides in the instructions for use (ifu) or in the user manual.However, the customer has to qualify their operational workflow.The customer has to define the appropriate amount of urine to put on their slide, and the best settings for getting the highest staining performances with their system.Under good microbiological practices, when a sample is a liquid, the smears are carried out using the centrifugation pellets.However, it could be done directly from urine (liquid) with the correct amount.Microbiology handbooks state that sufficient volume must be used for liquid samples that are not centrifuged, so the cells can be visible.The root causes of the customer¿s staining results are user error (not enough volume of urine put on the slide), and lack of information in the previ color® user manual regarding the volume of urine to put on a slide.A change request (28284) has been initiated to address the user manual.During the investigation, no issues were found regarding the previcolor® gram instrument v2 system.
|