(b)(4).This report is being submitted due to a retrospective review conducted under capa (b)(4).On (b)(6) 2017, fse arrived at the site to address the reported event.Fse cleaned the large syringe lead screw, tightened the connections, checked for leaks, and replaced the sample syringe seal.He was subsequently able to run patient samples without issues.No further action was required by field service.The most probable cause of the reported event was due to a fault/ failure of the large syringe.
|
On (b)(6) 2017, the customer reported "large syringe error 706" and low total area counts with their g8 analyzer.Technical support (ts) instructed the customer to verify the hemolysis waste (w/h) was full and suggested they change the sample needle.The customer called back the following day stating that the error had not resolved after changing the sample needle.On (b)(6) 2017 field service engineer (fse) was dispatched to address the reported event, which resulted in delayed reporting hba1c patient results.There was no indication of patient intervention or adverse health consequences due to the delay in reporting.
|