On (b)(6) 2022, abbott point of care was contacted by a customer regarding i-stat pt/inr cartridges that yielded a suspected discrepant pt/inr result on a 94 year old male patient with atrial fibrillation.There was no additional patient information available at the time of this report.Return product is not available for investigation.Method, date, result.I-stat, (b)(6) 2022, >4.5.Acl top 750, (b)(6) 2022, 2.8.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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