On (b)(6) 2015, abbott point of care was contacted by a customer regarding i-stat eg7+ cartridges that yielded suspected discrepant potassium, sodium and hemoglobin results on a (b)(6) female patient.There was no additional patient information at the time of this report.Return product is not available for investigation.Date:(b)(6) 2016: method: i-stat, k:>9.0, na: 112, hb:8.8, time: 11:00am, sample: a.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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