On (b)(6) 2015, abbott point of care was contacted by a customer regarding i-stat pt/inr cartridges that yielded unexpected results on a patient.There was no additional patient information available at the time of this report.I-stat inr = 4.5 ; lab inr = 2.3.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)(4) 2017 at abbott point of care ((b)(4)).
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