On (b)(6) 2020, abbott point of care was contacted by a customer regarding i-stat pt/inr cartridges that yielded a suspected discrepant pt/inr result of 2.5 on a (b)(6) year old female patient.The customer stated the patient came in with a mild cardio issue.Testing was performed to monitor the patient inr.The patient was not on coumadin or warfarin.There was no patient information available at the time of this report.Return product is not available for investigation.Method: i-stat, date: (b)(6) 2020, collected: 14:29, tested: 14:29, inr: 2.5.Lab/acl top, (b)(6) 2020, 14:33, 15:13, 1.0.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 patient is not on coumadin/warfarin and product was being used outside its intended use.The i-stat® pt/inr test is a whole blood determination of the prothrombin time used for monitoring oral anticoagulant (coumadin or warfarin) therapy.Reference cti sheet: prothrombin time pt/inr art: (b)(4).The investigation is underway.
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