A field service engineer was dispatched who arrived at the site to address the reported event.He took photographs, and inspected the device; then placed an order for a replacement.Upon receipt, the replacement rps computer was to be installed by a clinical support specialist.No further action was required by field service.The most probable cause of the reported event was due to mechanical fault/ failure of the reporting software computer.(b)(4).This report is being submitted due to a retrospective review conducted under capa (b)(4).
|
On (b)(6) 2017, the customer reported a "rear fan failure" from the reporting software (rps) computer with their g8 analyzer.A field service engineer (fse) was dispatched on (b)(4) 2017 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.
|