On (b)(6) 2017, abbott point of care was contacted by a customer regarding i-stat pt/inr cartridges that yielded unexpected results on an (b)(6) female patient.There was no additional patient information available at the time of this report.Date of testing: (b)(6) 2017.Method: pt: inr: sample: i-stat, 78.0, 7.1, a, sysmex ca-1500, 25.5, 2.4, b.At the time of the event there was no indication of a product malfunction based on the information provided and assessed by apoc; however, this mdr is a retrospective filing in response to an observation from an fda inspection conducted may 8th to 12th, 2017 at abbott point of care (b)(4).
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