Patient Problem
No Consequences Or Impact To Patient (2199)
Event Date 03/04/2020
Event Type
malfunction
Manufacturer Narrative
(b)(4).No customer returns were available.Historical quality metrics were reviewed and no adverse trend was identified for the customer's issue.Complaint searches determined that there is normal complaint activity for the likely cause lot.Labeling was reviewed and found to be adequate.Based on the available information, no product deficiency was identified.
Event Description
The customer observed falsely elevated magnesium results: initial 11.66 mg/dl; repeat 1.8 mg/dl on the architect c16000 system.The customer's reference range is 1.6 to 2.6 mg/dl.There was no impact to patient management reported.