Updated information in sections: d4 - expiration date updated from blank to 3/31/2024 , g1, h4 - device mfg date updated from blank to 3/3/2023 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.Data and information provided by the customer were reviewed and support the complaint issue.Ticket search by lot indicates that the complaint lot performs as expected.Ticket trending review did not identify any trends.Device history review did not identify any non-conformances or deviations with the complaint lot.Labeling was reviewed and adequately addresses the current issue.Based on the investigation, no systemic issue or deficiency of the architect carbon dioxide reagent, lot 63532uq02, was identified.
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The customer observed falsely elevated carbon dioxide results generated on the architect c4000 analyzer for multiple patients.The following data was provided (normal range 22-29 meq/l): sample id (b)(6) initial result = 30.24 mmol/l, repeat = 25.23 mmol/l sample id (b)(6) initial result = 33.15 mmol/l, repeat = 24 mmol/l sample id (b)(6) initial result = 29.87 mmol/l, repeat = 22.54 mmol/l sample id (b)(6) initial result = 33.45 mmol/l, repeat = 24 mmol/l sample id (b)(6) initial result = 31.28 mmol/l, repeat = 19.1 mmol/l no impact to patient management was reported.
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