Additional narrative: this report is being submitted due to a retrospective review conducted under capa (b)(4).(b)(4).Device evaluation by manufacturer: the field service engineer (fse) was dispatched on (b)(6) 2016.The fse replaced the large syringe tip and found crystal build up on the rotor seal, replaced the seal.The engineer cleaned the dried buffer from inside the instrument, rebooted the instrument and allowed the system to do a complete initialization.The fse ran 38 samples with no issues.The customer reportedly ran calibrators and controls and patients with no issues.The g8 was working as intended.No further action required by fse.The probable cause of the event was a clogged rotor seal.
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