Catalog Number 07K65-34 |
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 03/13/2024 |
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 architect free t4 results for four patients on architect i2000sr, serial numbers (b)(6).The results were lower when the samples were repeated.The following data was provided: (b)(6): (b)(6) 2024 sample 1: initial test: >5 ng/dl retest: 1.22 ng/dl (b)(6) 2024 sample 2: initial test: >5 ng/dl retest: 1.28 ng/dl another device: (b)(6): sample 3: initial test: 2.79 ng/dl retest: 1.19 ng/dl sample 4: initial test: 2.05 ng/dl retest: 1.31 ng/dl 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.Section b5 descibe event or problem was updated with: additional data for two more patients provided (b)(6) 2024: 1st sample = initial result = 2.37 repeat 1.13 ng/dl.2nd sample = initial result = 2.03 repeat 1.21 ng/dl.
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Event Description
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The customer observed falsely elevated architect free t4 results for four patients on architect i2000sr, serial numbers (b)(6).The results were lower when the samples were repeated.The following data was provided: (b)(6): (b)(6) 2024.Sample 1: initial test: >5 ng/dl.Retest: 1.22 ng/dl.(b)(6) 2024.Initial test: >5 ng/dl.Retest: 1.28 ng/dl.Another device: (b)(6): sample 3: initial test: 2.79 ng/dl.Retest: 1.19 ng/dl.Sample 4: initial test: 2.05 ng/dl.Retest: 1.31 ng/dl.Additional data for two more patients provided (b)(6) 2024: 1st sample = initial result = 2.37 repeat 1.13 ng/dl.2nd sample = initial result = 2.03 repeat 1.21 ng/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, device history record review, and labeling review.Additionally, in-house testing was performed.Return testing was not completed as returns were not available.Data and information provided by the customer were reviewed and support the complaint issue.A search for similar complaints did identify an increase in complaint activity, however, no related trends were identified regarding commonalities for lot number 56001ud00 and issue for the product.Additionally, in-house performance testing was completed which indicates the product is performing as expected.The device history record review did not identify any nonconformances, potential nonconformances or deviations associated with lot number 56001ud00 and the complaint issue.Labeling was reviewed and adequately addresses the customer¿s issue.Based on the investigation, no systemic issue or deficiency of the architect free t4 for lot 56001ud00 was identified.Section d4 catalog number and primary udi updated to (b)(4) with size code change from 24apr2024.
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Event Description
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The customer observed falsely elevated architect free t4 results for four patients on architect i2000sr, serial numbers (b)(6).The results were lower when the samples were repeated.The following data was provided: (b)(6): (b)(6) 2024 sample 1: initial test: >5 ng/dl retest: 1.22 ng/dl.(b)(6) 2024 sample 2: initial test: >5 ng/dl retest: 1.28 ng/dl.Another device: (b)(6): sample 3: initial test: 2.79 ng/dl retest: 1.19 ng/dl.Sample 4: initial test: 2.05 ng/dl retest: 1.31 ng/dl.Additional data for two more patients provided (b)(6) 2024: 1st sample = initial result = 2.37 repeat 1.13 ng/dl 2nd sample = initial result = 2.03 repeat 1.21 ng/dl no impact to patient management was reported.
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Search Alerts/Recalls
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