On (b)(6) 2019, abbott point of care was contacted by a customer regarding i-stat cg4+ cartridges that yielded a suspected discrepant lactate results on a (b)(6) year old male patient with neck and eye pressure.There was no patient information available at the time of this report.Return product is available for investigation.Method: i-stat, date: 11/19/2019, collected: 9:05, tested: 9:06, result: 1.89 mmol/l.I-stat, 11/19/2019, 9:10, 9:11, 3.20 mmol/l.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 investigation is underway.
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