On (b)(6) 2016, a customer reported high total areas on the g8 instrument.However, when the customer repeats the sample, the total areas are normal.The customer is unable to run patient samples on hba1c diabetes assay.On (b)(6) 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.
|