On (b)(6) 2023, abbott point of care was contacted by a customer regarding i-stat pt/inr cartridges that yielded suspected discrepant inr results a 53 year old female patient seen for a mechanical valve replacement.There was no additional patient information available at the time of this report.Return product is available for investigation.Method date collected tested inr sample i-stat (b)(6) 2023 02:23 02:23 4.0 whole blood- a.Stago (b)(6) 2023 02:02 ni 2.6 plasma- b.Pt/inr, intended use the i-stat pt, a prothrombin time test, is useful for monitoring patients receiving oral anticoagulation therapy such as coumadin ® or warfarin.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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