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) female patient.There was no additional patient information available at the time of this report.(b)(6).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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