On (b)(6) 2021, abbott point of care was contacted by a customer regarding i-stat cg8+ cartridges that yielded suspected discrepant hematocrit results of 28.0 & 23.0 on a patient.There was limited information and no patient information.Product lot information was not presented, but requested.Method, date, tested, hb , hct.I-stat, (b)(6) 2021, 01:10, 9.5 g/dl, 28.0 %pcv.Lab, (b)(6) 2021, 03:00, 4.2 g/dl, 16.3 %pcv.I-stat, (b)(6) 2021, 03:06, 7.8 g/dl, 23.0 %pcv.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 limited information available that suggests the product was not performing within the variability of the assay.Product lot information was not presented, but requested.The investigation is underway.
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Apoc incident: # (b)(4) the investigation was completed on 18-aug-2022.Multiple attempts to obtain the cg8+ lot number from the customer were unsuccessful.Two cg8+ lots that were shipped to the customer before the test date of (b)(6) 2021, w21298 and w21316, were investigated.A review of the device history records confirmed the lots passed finished goods release criteria.Retained cartridge testing was not possible as the two potential cg8+ lots were expired (24-jun-2022 for lot w21298 and 12-jul-2022 for lot w21316) before the opening of the investigation.No deficiency has been identified.
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