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 patient.There was no patient information available at the time of this report.Return product is not available for investigation.Method: i-stat, date: 10/09/2019, result: 5.4, sample: fingerstick.Stago, 10/09/2019, 3.6, plasma from citrate tube.Information received from the customer containing results from 1,056 comparisons of patient results tested on the i-stat pt/inr test and stago prothrombin time test. each paired result was evaluated independently.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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