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Model Number 03P6824 |
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 05/10/2023 |
Event Type
malfunction
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Manufacturer Narrative
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An evaluation is in process.A final report will be submitted when the evaluation is complete.All available patient information was included.Additional patient details are not available.
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Event Description
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The customer observed falsely elevated magnesium results generated on the architect c4000 for multiple patient samples.The following data was provided (customer¿s reference range 0.7-1.1 mmol/l): (b)(6) 2023 sample id 681167149 initial = 3.543 mmol/l, repeat = 1.504 mmol/l, 0.808 mmol/l, 0.815 mmol/l, 77% no impact to patient management was reported.
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Manufacturer Narrative
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Additional information d4 - expiration date and h4 - device mfg date.The complaint investigation for falsely elevated 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.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 with the complaint lot.The overall performance of architect magnesium reagents was reviewed using data gathered from customers worldwide.The patient data was analyzed and compared to an established control limit.This evaluation indicated that the patient median result is within the established control limits.Therefore, no unusual reagent lot performance was identified for lot 46424ud00.Labeling was reviewed and sufficiently addresses the customer's issue.Based on the investigation, no systemic issue or deficiency with the architect magnesium reagent kit, lot number 46424ud00, was identified.
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Event Description
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The customer observed falsely elevated magnesium results generated on the architect c4000 for multiple patient samples.The following data was provided (customer¿s reference range 0.7-1.1 mmol/l): 10may2023 sample id (b)(6) initial = 3.543 mmol/l, repeat = 1.504 mmol/l, 0.808 mmol/l, 0.815 mmol/l, 77%.No impact to patient management was reported.
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Search Alerts/Recalls
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