On (b)(6) 2019, abbott point of care was contacted by a customer regarding i-stat pt/inr cartridges that yielded a suspected discrepant pt/inr result of 4.5 on a (b)(6) year old female patient.There was no additional patient information available at the time of this report.Return product is available for investigation.Method: i-stat, date: (b)(6) 2019, tested: 1015, result: 4.5, sample: a.Stago, (b)(6) 2019, ni, 2.90, b.Collection times not provided.There are no injuries associated with this event.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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