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 32 year old female patient.There was no additional information available at the time of this report.Return product is not available for investigation.Method date pt i-stat on (b)(6) 2023 3.8 acl top on (b)(6) 2023 2.9 collection/test times not provided 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.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.
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