Apoc incident # (b)(4).Apoc labeling was evaluated during the investigation as pertaining to the event.The investigation was completed on 06/15/2017.Retain product was tested and functioning according to specification.Return product is not available for investigation.Investigation: the device history record (dhr) for this lot was reviewed.The lot passed finished goods (fg) release criteria.Forty retained cartridges from the lot were tested using whole blood (wb) and i-stat level 1 control (l1).Testing met the acceptance criteria found in q04.01.003 rev.X, 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 lot is meeting specification.The treatment for elevated lactate would be fluids, antibiotics, oxygen and observation.No treatment was administered based on the > 20 mmol/l result.
|
On (b)(6) 2016, abbott point of care was contacted by a customer regarding i-stat cg4+ cartridges that yielded suspected discrepant lactate result on a (b)(6) year old male patient with epigastric abdominal pain.There was no additional 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).
|