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Catalog Number 07P57-30 |
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 07/13/2023 |
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.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 alinity c calcium results (above normal range) for two patients.One patient was called back to the emergency department for a second blood draw that generated normal results (not provided).The following data was provided.Sid: (b)(6), 1st run = 3.258 mmol/l (b)(6) 2023 12:52, 2nd run = 4.211 mmol/l (b)(6) 2023 02:25, 3rd run = 3.291 mmol/l (b)(6), 2023 11:45, 4th run = 3.232 mmol/l (b)(6), 2023 11:53.Sid (b)(6), 1st run = 3.015 mmol/l (b)(6) 2023 10:52, 2nd run = 4.925 mmol/l (b)(6) 2023 02:23, 3rd run = 3.955 mmol/l (b)(6) 2023 11:44, 4th run = 3.910 mmol/l (b)(6) 2023 11:53.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.Trending review determined no trend for the issue for the product.Historical complaint review determined there is normal complaint activity for the lot number.Device history record review did not show any potential non-conformances, or deviations.Labeling was reviewed and found to adequately address the issue.File sample analysis was not performed as the sample was retested and gave acceptable results.In addition, quality control was performing as expected.Based on the investigation, no deficiency for lot number 23745un22 was identified.
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Event Description
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The customer observed falsely elevated alinity c calcium results (above normal range) for two patients.One patient was called back to the emergency department for a second blood draw that generated normal results (not provided).The following data was provided.Sid (b)(6) 1st run = 3.258 mmol/l (b)(6) 2023 12:52 2nd run = 4.211 mmol/l (b)(6) 2023 02:25 3rd run = 3.291 mmol/l (b)(6) 2023 11:45 4th run = 3.232 mmol/l (b)(6) 2023 11:53 sid (b)(6) 1st run = 3.015 mmol/l (b)(6) 2023 10:52 2nd run = 4.925 mmol/l (b)(6) 2023 02:23 3rd run = 3.955 mmol/l (b)(6) 2023 11:44 4th run = 3.910 mmol/l (b)(6) 2023 11:53.No impact to patient management was reported.
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Search Alerts/Recalls
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