On 08/21/2020, abbott point of care was contacted by a customer regarding i-stat pt/inr cartridges that yielded a suspected discrepant pt/inr result of 5.1 on a (b)(6) year old female patient presented for routine pt/inr check.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) 2020, collected: 09:22, tested: 09:23, inr: 5.1, sample: skin puncture-first drop of blood; sysmex c55 100, (b)(6) 2020, 10:05, ni, 2.68, venipuncture into blue top- centrifuged for plasma.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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