On (b)(4) 2016, abbott point of care was contacted by a customer regarding i-stat creatinine cartridges that yielded suspected discrepant results on a (b)(6) male patient in for a ct of carotids.There was no additional patient information available at the time of this report.Return product is not available for investigation.Date: (b)(6) 2015; sample: a; collected: 0902; tested: 0906; method: i-stat; result: 4.3.(b)(6) 2015; b; 1300; 1341 ; lab; 1.0.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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