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 female patient who was diagnosed with acute bronchitis.There was no additional patient information available at the time of this report.Time, date of i-stat test, i-stat result: 04/08/16, 12:54, 41.5 iu/l.Time, date of beckman dxi test, lab result: drawn: 12:54,, results: 13:59 <5.0 iu/l.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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