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 had previously undergone a hysterectomy.The patient was diagnosed with pneumonia.There was no additional patient information available at the time of this report.Date: (b)(6) 2016, time: 1621, i-stat: 32.7 iu/l, lab (beckman coulter dxi): <5.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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