Patient Problem
No Known Impact Or Consequence To Patient (2692)
Event Date 09/21/2015
Event Type
malfunction
Manufacturer Narrative
A field service engineer was dispatched on.(b)(4) 2015.The fse arrived at the site for a sample error and by trouble shooting he found that the needle had a slight bend and also the alignment was off and needed to be adjusted.To verify the fse ran 2 racks of patients and qc (quality control) with no sample errors.No further action is required by field service.The g7 analyzer was functioning as intended and errors cleared.The most probable cause of the reported event was the sampling unit, fault or failure of sample unit a bent needle and alignment needed to be adjusted.(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 rack movement issues, racks not being indexed correctly and sampling between tubes with their g7 analyzer.The customer is unable to run hba1c patient samples.A 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.