The complaint investigation included a review of data and information provided by the customer, search for similar complaints, ticket trending review, labeling review, and device history record review.Return testing was not completed as returns were not available.The patient sample was reanalyzed using the same reagent with no issues; acceptable results were generated.A review of tickets determined that there is normal complaint activity for lot 35289un20.Review of tracking and trending reports did not identify any related trends for the issue for the product.A review of the manufacturing documentation did not identify any issues associated with the customer's observation.A review of the product labeling concluded that the issue is sufficiently addressed.Based on the investigation, no systemic issue or deficiency of the architect magnesium reagent, lot number 35289un20 was identified.
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The customer reported falsely elevated magnesium results generated on the architect c8000 processing module for two patients.The results provided from the samples collected on (b)(6) 2020 were: patient 1 initial result was 6.3 mg/dl, repeated 1.9 mg/dl; patient 2 initial result was 6.3 mg/dl, repeated 1.9 mg/dl; (customer reference range 1.7 mg/dl to 2.8 mg/dl).No impact to patient management was reported.
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