On (b)(6) 2018, abbott point of care was contacted by a customer regarding i-stat cg4+ cartridges that yielded suspected discrepant results on an (b)(6) male patient who had fallen at home and was found laying on the floor outside the bathroom.Per the patient and family, he laid on the floor for 3 days, before being found by family.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.The investigation is underway.
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