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 >5.0 inr on a (b)(6) year old male on coumadin.However, there was no information or results at the time.On (b)(6) 2019 they called and provided results and patient information.The patient was treated on the stago result.There was no additional patient information available at the time of this report.Return product is available for investigation.Method: i-stat, date: 06/14/2019, collected: 09:38, tested: 09:38, result: >5.0.Stago, 06/14/2019, ni, ni, 4.1.There are no injuries associated with this event.At this time there is no reason to suspect a malfunction exists.The actual i-stat result is unknown since the customer has the analyzer customized to report >5 for pt/inr.It is being assumed that the result was high but cannot be confirmed.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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