Catalog Number 08P19-25 |
Device Problem
High Test Results (2457)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/24/2023 |
Event Type
malfunction
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Manufacturer Narrative
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An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
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Event Description
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The customer observed a falsely elevated magnesium result generated on the alinity c processing module for one sample.The following data was provided: (b)(6) 2023 initial result = 6.85 mg/dl, repeat on another alinity = 1.99 mg/dl no impact to patient management was reported.
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Manufacturer Narrative
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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 without indication for any additional issue.A search for similar complaints did not identify an increase complaint activity for lot 53416ud00.A review of tracking and trending did not identify any trends for the issue for the product.Device history record review did not identify any non-conformances or deviations associated with lot number 53416ud00 and the complaint issue.Labeling was reviewed and sufficiently addresses the customer¿s issue.Based on the investigation, no systemic issue or deficiency of the alinity c magnesium reagent for lot 53416ud00 was identified.
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Event Description
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The customer observed a falsely elevated magnesium result generated on the alinity c processing module for one sample.The following data was provided: (b)(6) 2023 initial result = 6.85 mg/dl, repeat on another alinity = 1.99 mg/dl no impact to patient management was reported.
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Search Alerts/Recalls
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