On (b)(6) 2016, a customer reported x and z axis errors on the g8 instrument.The customer stated that for the z axis errors, the guide rod and lead screw shaft were cleaned but the bent sample needle was due to it striking the side of a tube.The customer is unable to run patient samples on hba1c diabetes assay.On (b)(4) 2016, a field service engineer (fse) was dispatched to address the reported event, which resulted in delay in reporting of patient results for hba1c.There is no indication of any patient intervention or adverse health consequences due to the delay in reporting of patient results.
|