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 75 year old male patient with deep vein thrombosis.There was no additional patient information available, at the time of this report.Return product is not available for investigation.Method: i-stat, date:(b)(6) 2022, result: >4.5.Method: acl top 750, date: (b)(6) 2022, results: 3.8.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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