Patient Problem
No Known Impact Or Consequence To Patient (2692)
Event Date 07/01/2020
Event Type
malfunction
Manufacturer Narrative
Patient identifier = (b)(6).A review of tickets determined that there is normal complaint activity for lot 74519un20.Trending review determined no adverse trend for false elevated results for the magnesium reagent.Return testing was not completed as returns were not available.A review of the product labeling concluded that the issue is sufficiently addressed.Based on the investigation, no systemic issue or deficiency of the magnesium reagent, lot number 74519un20 was identified.
Event Description
The customer reported false elevated architect magnesium results on one patient.The results provided were: on (b)(6) 2020 sid (b)(6) = >9.5 mg/dl, repeated 9.7, 1.82 mg/dl.No impact to patient management was reported.