On (b)(6) 2019, abbott point of care was contacted by a customer regarding i-stat ec8+ cartridges that yielded suspected discrepant results on a (b)(6) male patient with respiratory distress.There was no additional patient information available at the time of this report.(b)(6).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 the limited information available that suggests the product was not performing within the variability of the assay.Customer has not provided, cartridge lot, or patient information as requested.The investigation on hold at this time unless cartridge lot information is obtained.
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