Catalog Number 03P68-32 |
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 01/08/2024 |
Event Type
malfunction
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Event Description
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The customer observed a falsely elevated magnesium result generated on the architect c16000 processing module for one sample.(customer provided reference range was 0.7-1.1 mmol/l) the initial test result was 3.71mmol/l, the retest results were 0.84 mmol/l,0.83 mmol/l, 0.84 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.All available patient information was included.Additional patient details are not available.
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Manufacturer Narrative
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The complaint investigation for falsely elevated magnesium results generated on the architect c16000 processing module 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.Review of all the information provided by the customer was reviewed.A ticket search by lot did not identify an increase in complaint activity for the current issue.A review of tracking and trending did not identify any trends for the complaint issue.Device history review did not identify any non-conformances or deviations with the complaint lot.Labeling was reviewed and sufficiently addresses the customer¿s issue.Based on the investigation, no systemic issue or deficiency of the magnesium reagent lot 46181un23 was identified.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 a falsely elevated magnesium result generated on the architect c16000 processing module for one sample.(customer provided reference range was 0.7-1.1 mmol/l) the initial test result was 3.71mmol/l, the retest results were 0.84 mmol/l,0.83 mmol/l, 0.84 mmol/l no impact to patient management was reported.
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Search Alerts/Recalls
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