Apoc incident (b)(4).Apoc labeling was evaluated during the investigation as pertaining to the event.The investigation was completed on 10/31/2016.Retain product was tested and found to be functioning according to specification.Lot#: a16105, manufacture date: 04/14/2016, expiration date: 09/28/2016.F16124, 05/03/2016, 10/14/2016.Investigation: the customer reported observing an unexpected result while using b-hcg cartridges from lots a16105 and f16124 to test a patient sample.The device history record for these lots was reviewed.The lots passed finished goods release criteria.Forty retained cartridges from each lot were tested using whole blood.Testing met the acceptance criteria found in q04.01.003 rev.Z, appendix 1 - product complaint level 2 and level 3 investigation procedure.No deficiency has been identified.Assessment: the complaint investigation concluded there was no product deficiency and that the i-stat cartridge lots are meeting specification.
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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 been diagnosed with cancer and was undergoing chemotherapy.There was no additional patient information available at the time of this report.(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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