The complaint investigation for false elevated magnesium results included a search for similar complaints, and the review of complaint text, trending data, labeling, and device history records.Return testing was not performed as returns were not available.Ticket review determined that there is normal complaint activity for lot number 81717un21.The trending review determined no trends identified for falsely elevated patient results for the product.File sample analysis was not performed as samples when retested, generated lower normal results.The preventative maintenance log was okay and quality controls were within range during the time of testing.Worldwide data was reviewed and determined that the patient median result for magnesium reagent lot number 81717un21 is within established control limits, indicating the assay is performing as expected.A review of the device history record did not identify any non-conformances or deviations.Labeling was reviewed and was found to adequately address the issue under review.Based on the investigation, no systemic issue or deficiency of magnesium reagent, lot number 81717un21 was identified.
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