(b)(4).This report is being submitted due to a retrospective review conducted under capa (b)(4).On (b)(6) 2016, ts conducted follow-up with the customer over-the-phone to address the reported event.Ts discussed the shift in bias which may result when calibrators were switched, affecting subsequent peer and target values.The customer was instructed to recalibrate the device with lot 5001 & 5002 and rerun.No further issues were noted and no further action was required.The most probable cause of the reported event was due to cap survey bias.
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On (b)(6) 2016, a customer a drop in cap survey results with their g8 analyzer.The customer stated that they had recently switched to new calibrators.On (b)(6) 2016, technical support specialist (tss) spoke with the customer on the phone to address the reported event, which resulted in delayed reporting a hba1c patient result.There was no indication of patient intervention or adverse health consequences due to the reported event.
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