(b)(4).This report is being submitted due to a retrospective review conducted under capa (b)(4).On (b)(6) 2016, an fse visited the customer to address the reported event.During servicing, fse ran precision testing with acceptable results.However, fse replaced the rotor seal, stator face, and sample needle as a precaution.The instrument was verified as operational.There was no further action required by fse.The most probable cause of the reported event stator face and rotor seal.
|
On (b)(6) 2016, a customer reported intermittent high pressure errors with their g8 analyzer.The customer verified that the column count was 1214, which indicates a pressure of 8.3.When the customer ran the pump, they found the system pressure to be 8.39.After disconnecting the output peek tubing from the top of the filter assembly, the pump pressure bottomed out.A field service engineer (fse) was dispatched to address the reported event, which resulted in delayed reporting hga1c patient results.There was no indication of patient intervention or adverse health consequences due to the delay in reporting.
|