On 09-sep-2021, abbott point of care was contacted by a customer regarding i-stat cg4+ cartridge that yielded a suspected discrepant lactate result on a 69 year old male patient.The patient was admitted and discharged the same day.There was no additional patient information available at the time of this report.Method: i-stat, date: (b)(6) 2022, result: 2.54 mmol/l; ekf, (b)(6) 2022 1.2 mmol/l; test times not provided.There are no injuries associated with this event.At this time there is no reason to suspect a malfunction exists.The reporting decision was based on the limited information available that suggests the product was not performing within the variability of the assay.The investigation is underway.
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Apoc incident: # (b)(4).The investigation was completed on 04-oct-2022.A review of the device history records confirmed the cartridge lots passed finished goods release criteria.Retained cartridge testing met the acceptance criteria found in q04.01.003 rev.Ak, appendix 1- product complaint level 2 and level 3 investigation procedure, in all cases except for lot m22088 in i-stat level 2 (l2) control fluid (test id jb797a) where the sample size was too low (<17) to assess points outside total allowable error (ea).No deficiency has been identified.
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