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 a (b)(6) year old male with a 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: 10:37, tested: 10:37, result: 4.7.I-stat, 12/30/2019, 10:43, 10:43, 4.8.Lab, 12/30/2019, ni, 11:33, 3.6.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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