Patient Problem
No Known Impact Or Consequence To Patient (2692)
Event Date 11/09/2015
Event Type
malfunction
Manufacturer Narrative
A field service engineer was not dispatched.Tss conducted follow-up with the customer over-the-phone to address the reported event.Tss advised to replace the sample needle.No further action required by field service.The most probable cause of the reported event was due to a defective clogged sample needle (b)(4).This report is being submitted due to a retrospective review conducted under capa (b)(4).
Event Description
On (b)(6) 2015, a customer reported low ta with their g8 analyzer.A field service engineer (fse) was dispatched on (b)(6) 2015 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.