Catalog Number 01L75-25 |
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 12/18/2023 |
Event Type
malfunction
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Manufacturer Narrative
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A1 patient identifier: complete sample id is (b)(6).All available patient information was included.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
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Event Description
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The customer reported falsely elevated architect cyclosporine, which reportedly occurred on approximately 3 patients.The customer stated that the results were questioned, and samples were processed again with a new pretreatment set up, and result was lower.The customer provided the follow data for 1 patient: customer reference range is: 100.0 ng/dl to 400 ng/ml sample id (b)(6): on 12/18 initial result was 167.5, and repeat result was <30 and <30.There was no reported impact to patient management.
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Event Description
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The customer reported falsely elevated architect cyclosporine, which reportedly occurred on approximately 3 patients.The customer stated that the results were questioned, and samples were processed again with a new pretreatment set up, and result was lower.The customer provided the follow data for 1 patient: customer reference range is: 100.0 ng/dl to 400 ng/ml sample id (b)(6): on 12/18 initial result was 167.5, and repeat result was <30 and <30.There was no reported impact to patient management.Update: additional information received: the customer reported that the issue was due to a human error with the preparation.
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Manufacturer Narrative
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Additional information can be seen in section b5.
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Event Description
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The customer reported falsely elevated architect cyclosporine, which reportedly occurred on approximately 3 patients.The customer stated that the results were questioned, and samples were processed again with a new pretreatment set up, and result was lower.The customer provided the follow data for 1 patient: customer reference range is: 100.0 ng/dl to 400 ng/ml.Sample id (b)(6): on (b)(6), initial result was 167.5, and repeat result was <30 and <30.There was no reported impact to patient management.Update: additional information received: the customer reported that the issue was due to a human error with the preparation.
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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, and labeling review, and device history record review.Return testing was not completed as returns were not available.Data and information provided by the customer were reviewed and support the complaint issue without indication for any additional issue.Ticket search by lot did not identify an increase in complaint activity for the complaint lot.Ticket trending review has not identified any related trends in which there was a product issue.Labeling was reviewed and was found to address the customer reported issue.Based on the available information, no systemic issue or deficiency was identified for the architect cyclosporine reagent lot 55721fp00.
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Search Alerts/Recalls
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