On (b)(6) 2016, abbott point of care was contacted by a customer regarding i-stat b-hcg cartridges that yielded a suspected false positive result on a (b)(6) female patient who presented in the ed after a fall in the shower.There was no additional patient information available at the time of this report.On (b)(6) 2016: 09:10 i-stat 224 iu (no retest), 09:45 sp combo kit negative (qualitative only).Customer took the plasma separator tube and ran (refrigerated) plasma: 17:30 i-stat 103, 19:07 vitros <2.39 (negative).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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