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 of 3.2 on a patient.There was no patient information available at the time of this report.Method: i-stat, date: 10/08/2019, collected: ni, tested: 0842, inr: 3.2.Lab, 10/08/2019, 0850, 0915, 1.4.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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