(b)(4).There was no investigation performed.Product was not returned for investigation.Investigation: n/a.Assessment: no repeats on the i-stat or laboratory instrument.The reporter indicated that the same sample was tested on both the i-stat and the lab instrument.The i-stat results would be consistent with a sample drawn into an edta tube.Only samples collected in un-heparinized or lithium or sodium heparinized blood collection devices may be used for testing using any of the i-stat chemistry cartridges.Edta may not be used with any cartridge type other than the glucose or bnp cartridges.Edta will cause a clinically significant error in sodium, potassium, chloride and hematocrit results and may affect other chemistry tests (b)(6) - sample collection).Use of an edta tube would decrease the ionized calcium and increase k+.No information regarding the patient, sample type or sample handling were available upon repeated follow up.
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On (b)(6) 2015, abbott point of care was contacted by a customer regarding i-stat1 analyzer (b)(4) that had lower results on k and na on a patient.There was no patient information at the time of this report.There was no repeat on i-stat.No reply from the customer.Return product is not available for investigation.Test: na, i-stat: 121, chemistry machine: 140; test: k, i-stat: >9, chemistry machine: 5.0.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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