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 result in an (b)(6) year old female with diagnosis of a cerebrovascular accident.There was no additional patient information available at the time of this report.Return product is available for investigation.Method: i-stat, date: 12/30/2019, collected: 13:40, tested: 13:40, result: 5.0.I-stat, 12/30/2019, 13:47, 13:47, 4.1.Lab, 12/30/2019, ni, 14:15, 2.5.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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