On 06/28/2016, abbott point of care was contacted by a customer regarding i-stat cg8+ cartridges that yielded suspected discrepant potassium (k) result on a (b)(6) year old male patient presented with renal failure.The customer stated the patient indicated they felt ill during the dialysis procedure and while been rush to the ed the patient coded.Sample was drawn for i-stat testing as part of code blue procedure.Patient is stable there were no injuries associated with this event, the patient was treated based on the lab results.There was no additional patient information available at the time of this report.Return product is not available for investigation.Method: i-stat; test time: 07:13; glu: 293; na: 139; k: 4.4; tco2: 24; hct:33.0.Architect; 08:25; 343; 141; 7.9; 21.5; 32.0.At the time of the event there was no indication of a product malfunction based on the information provided and assessed by apoc, however this mdr is a retrospective filing in response to an observation from an fda inspection conducted may 8th to 12th, 2017 at abbott point of care ((b)(4)).
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