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Model Number 08P1934 |
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 10/20/2021 |
Event Type
malfunction
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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 (b)(4) for one sample.On (b)(6) 2021 sid (b)(6) initial result on (b)(4) (lot 82496un21) = 0.66 mmol/l, repeat = 0.51 mmol/l, repeats on (b)(4) = 0.51 mmol/l and 0.50 mmol/l no impact to patient management was reported.
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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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Manufacturer Narrative
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The complaint investigation for falsely elevated alinity c magnesium results included a review of data and information provided by the customer, search for similar complaints, ticket trending review, labeling review, device history record review, and field data review.Return testing was not completed as returns were not available.Trending review did not identify any trends for the issue for the product.Device history record review did not identify any non-conformances or deviations with lots 28011ud00 and 82496un21 and the complaint issue.The overall performance of alinity c magnesium was reviewed using field data from customers worldwide and suggests that the product is performing acceptably.Also review of the data associated with reagent lots 28011ud00 and 82496un21, indicates the patient median is within the established limits.Therefore, no unusual reagent lot performance was identified with reagent lots 28011ud00 and 82496un21.Labeling was reviewed and sufficiently addresses the customer's issue.Based on our investigation, no systemic issue or deficiency with the alinity c magnesium reagent for lots 28011ud00 and 82496un21 was identified.Updated section g1 for updated contact information.Updated section b5 to include clarifiying information about lot numbers.Updated section d4 as catalog no changed from 08p19-34 to 08p19-30.
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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) 2021: sid (b)(6) initial result = 0.5 mmol/l on ac03519, repeat on ac03518 (lot 28011ud00) = 1.2 mmol/l.Additional data was provided by the customer: the customer observed a falsely elevated magnesium result generated on the alinity c processing module (ac03518) for an additional sample.(b)(6) 2021: sid (b)(6) initial result on ac03518 (lot 82496un21) = 0.66 mmol/l, repeat = 0.51 mmol/l, repeats on ac03678 = 0.51 mmol/l and 0.50 mmol/l no impact to patient management was reported.
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Search Alerts/Recalls
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