On (b)(6) 2017, abbott point of care was contacted by a customer regarding i-stat eg7+ cartridges that yielded suspected discrepant sodium (na) result on (b)(6) male patient born premature.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 was not available for investigation.Method , date, collection / test time , na (mmol/l) , sample specimen type : i-stat , (b)(6) 2017, 16:40pm / 16:42pm , 112 , a , whole blood (arterial) ; siemens vista, (b)(6) 2017 , 16:40pm / 16:42pm , 142 , b , whole blood (arterial) ; 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 (b)(6) 2017 at abbott point of care ((b)(4)).
|