On 19-jan-2023, abbott point of care was contacted by a customer regarding i-stat pt/inr cartridges that yielded a suspected discrepant inr result of 2.9 on a patient.There was no patient information available at the time of this report.Return product is available for investigation.Method : i-stat, date: 18-jan-2023, result (units): 2.9; method : lab, date: 18-jan-2023, result (units): 0.99.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.The customer reports that the patient is not on oral anticoagulant (coumadin or warfarin) therapy.As per prothrombin time, pt/inr ifu art: 715236-00s.The customer was advised of off label use and the intended use for the i-stat pt/inr.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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