On (b)(6) 2016, a customer reported the correlation results between this unit and another g8 did not correlate within standards on the g8 instrument.The customer noted that there was a low total area and the quality control and patient samples shifted lower than the other g8.Technical support advised the customer to change the column.The customer ran samples after the column was changed and found that the specimens >12.0 were not acceptable according to the sop.The customer is unable to run patient samples on hba1c diabetes assay.On 5-december-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.
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