On 29-aug-"2021", abbott point of care was contacted by a customer regarding i-stat cg8+ cartridges that yielded a suspected discrepant ionized calcium result of >250 mmol/l on a 60 year old female patient with cardiogenic shock.Return product is 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.Product lot information was not presented, but requested.The investigation is underway.
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