On (b)(6) 2018, abbott point of care was contacted by a customer regarding i-stat cg8+ cartridges that yielded suspected discrepant results on a (b)(6) year old male patient admitted with acute respiratory failure, cardiac arrest, pneumonia and septic shock.Undergoing extracorporeal membrane oxygenation (ecmo).There was no additional patient information available at the time of this report.Return product is available.Test date: (b)(6) 2018.Collect/test time: 10:23, 10:45, 11:09.Po2, 111, 159, 134.Pco2, 88.0, 34.6, 20.5.Ph, 7.16, 7.50, 7.59.Be, 0, 4 , -1.Hco3, 31.3, 26.8, 19.4.Hct, 38.0, 33.0, 32.0.K+, 4.9, 5.1, 4.2.Ica+, 1.16 , 1.07, 0.96.Glu, 122, 122, 112.So2 , 96.0, 100.0, 100.0.Na+, not reported.Hgb, not reported.Tco2, not reported.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 information available that suggests the product was not performing within the variability of the assay.The investigation is underway.
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