On (b)(6), 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 (b)(6) year male patient with a pacemaker and atrial fibration.There was no additional patient information available at the time of this report.Return product is available for investigation.Method: lab, date: 10/08/2019, collected: 09:25, tested: 13:30, inr: 7.8.I-stat, 10/08/2019, 15:00, 15:00, 4.5.Lab, 10/08/2019, 15:45, 18:10, 7.3.Lab, 10/09/2019, 13:48, 15:09, 5.0.I-stat, 10/09/2019, 14:13, 14:13, 2.7.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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