Siemens filed the initial mdr 9610806-2018-00052 on 15-jun-2018.Additional information (28-may-2018): the initial mdr indicated that a siemens field service engineer (fse) was dispatched to the customer's site.During this visit, the fse inspected the system and determined that the belt tension transport belt rack feeder was low.The fse observed analysis errors: 210 (accumulated error message), 3027 (too large difference to the initial value), and 3028 (level above vessel edge).The customer indicated that they loaded reagent vials correctly in the racks.The fse cleaned and re-greased the linear guide x transfer arms, removed and cleaned the rack feeder, and tightened the straps of the belt tension conveyor belt.The fse also removed, cleaned and ground checked the rear rack platform, offset values of the rack coupler, checked offset values of scanner and tube sensor and ran quality controls, which recovered acceptably.Siemens further investigated the instrument data and observed unexpected behavior of reagent volume over time.The difference in volume, from the time in which the reagent was inserted until the time the reagent was ejected, was less than expected with the performed measurements using the reagent vial.Siemens determined that "no clot" results were obtained when the level sensor did not detect the decrease in reagent volume, when processing a sample.The cause of the discordant "no clot" aptt results obtained on patient samples is unknown.The samples were not rerun on an alternate bcs xp system.The samples were only rerun on the initial bcs xp system.The system is performing according to specifications.No further evaluation of this device is required.
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