The complaint investigation for falsely decreased glucose result included a review of data and information provided by the customer, search for similar complaints, ticket trending review, device history record review, and labeling review.Return testing was not completed as returns were not available.The data and information provided by the customer were reviewed and support the complaint issue.A ticket search by lot indicates that the reagent lot performs as expected for this product.A review of the trending report did not identify any trends for the issue for the product.A review of the device history record did not identify any non-conformances or deviations with lot number 63052uq11 and complaint issue.A review of labeling was performed and found to sufficiently address the customer's issue.In this case, sample integrity issues at the time of testing could have contributed to the customer¿s observation.As part of the troubleshooting the same sample was rerun on the same instrument and two other instruments generated higher results.The quality control was performing within the expected ranges, which shows that the assay was performing as expected.Based on this investigation, no systemic issue or deficiency was identified with the glucose reagent, lot number 63052uq11.
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