On 30-aug-2021, abbott point of care was contacted by a customer regarding i-stat cg8+ cartridges that yielded a suspected discrepant po2 result on a (b)(6) year old male patient, unresponsive, defibrillation performed, laryngeal mask airway (lma) inserted.There was no additional patient information available at the time of this report.Return product is not available for investigation.(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 limited information available that suggests the product was not performing within the variability of the assay.The customer states that care was withdrawn because of anoxic brain injury and the patient expired (b)(6) 2021 at 21:08 the investigation is underway.
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