Device Problems
Device Issue (2379); Pressure Problem (3012)
Patient Problem
No Known Impact Or Consequence To Patient (2692)
Event Date 09/16/2016
Event Type
malfunction
Manufacturer Narrative
A field service engineer (fse) was dispatched who replaced the i-6 line to the filter.He restarted the device and primed the lines.The customer was subsequently able to run calibration and qc with no errors.No further action was required by the field service.The probable cause of the reported event was due to fault/ failure of the internal tubing.(b)(4).This report is being submitted due to a retrospective review conducted under capa-(b)(4).
Event Description
On (b)(6) 2016, the customer reported high pressure alarms after placement of a new column with their g8 analyzer.A field service engineer (fse) was dispatched on 15-sep-2016, to address the reported event,which resulted in delay in reporting of patient results hba1c.There was no indication of any patient intervention or adverse health consequences due to the delay in reporting of patient results.