On (b)(6) 2018, abbott point of care was contacted by a customer regarding i-stat pt/inr cartridges that yielded suspected discrepant results on a patient.There was no patient information, or test/collection times at the time of this report.Method: i-stat, result: 5; lab, 8.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 information available that suggests the product was not performing within the variability of the assay.It was determined that both the i-stat and lab results provided are above the therapeutic range.The investigation is underway.
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