Patient Problem
No Known Impact Or Consequence To Patient (2692)
Event Date 07/22/2015
Event Type
malfunction
Manufacturer Narrative
A field support specialist placed a phone call to the customer to troubleshoot the reported event.The customer was advised to order a new sample needle.The fse suggested if they want service they will need to issue an purchase order, no further action required.The most probable cause of the reported event was due to bent sample probe.(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 bent sample needle errors with their g8 analyzer.A field service engineer (fse) was not dispatched 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.