On (b)(6) 2015, abbott point of care was contacted by a customer regarding i-stat pt/inr cartridges that yielded unexpected results on an (b)(6)-year-old female patient.There was no additional patient information available at the time of this report.I-stat inr = 1.6, sysmex ca1500 inr = 3.7.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 (b)(6) 2017 at abbott (b)(6).
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