On (b)(6) 2016, abbott point of care was contacted by a customer regarding i-stat creatinine cartridges that yielded suspected discrepant results on a patient.There was no patient information available at the time of this report.Return product is not available for investigation.(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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