Lot/serial number was manufactured prior to udi compliance date; therefore, only a di is provided note: this event was previously reported in manufacturer report number 1415939-2016-00092 under the incorrect manufacturing site.Further investigation of the customer issue included a review of the complaint text, a search for similar complaints, review of instrument logs and a review of labeling.No adverse trend was identified for the customer's issue.Labeling was reviewed and found to be adequate.Based on all available information and abbott diagnostics' complaint investigation no product deficiency was identified.
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The customer observed falsely depressed co2 results on the architect c16000 analyzer.The following data was provided: initial 13.4, repeat 18.4, 22 meq/l.There was no impact to patient management reported.Neat sample - 13.4.When the sample was diluted one part sample to one part saline, the final (calculated) result was 18.4.When the sample was diluted one part sample to two parts saline, the final (calculated) result was 22.The patients acidosis is normal on blood gas analysis with a normal blood ph and bicarbonate result.
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