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 male with chest pain and seizures.There was no additional patient information available at the time of this report.Method: i-stat, date: 11/26/2019, time: 22:23, pt/inr: 55.9 / 5.0.Lab, 11/28/2019, 22:30, 28.1 / 2.81.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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