On (b)(6) 2019, abbott point of care was contacted by a customer regarding i-stat pt/inr cartridges that yielded a suspected discrepant pt/inr results on a (b)(6) year female patient with pain, and anxiety.There was no additional patient information available at the time of this report.Return product is not available for investigation.Method: i-stat, date: 10/25/2019, collected: 10:02, tested: 10:02, result: 3.9.Lab, 10/25/2019, 10:40, ni, 2.7.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.The investigation is underway.
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