On (b)(6) 2016, 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.Date of testing: (b)(6) 2016.Method: time: inr: sample: i-stat, 1:50, 5.6, a.Lab, unk, 1.8, b.I-stat, 3:01, 1.9, c.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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