Model Number 1L75-25 |
Device Problem
Low Test Results (2458)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/09/2022 |
Event Type
malfunction
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Event Description
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The customer observed falsely decreased architect cyclosporine result which questioned by physician on one patient.The results provided were: initial=63 ng/ml /repeated=69 ng/ml /redrawn and repeated on same patient=170 ng/ml and 180 ng/ml /initial specimen repeated=69 ng/ml there was no reported impact to patient management.
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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.The initial report was submitted under manufacturer report number 1415939-2022-00047-01 ((b)(4), usa as manufacturing site) with suspect medical device of architect cyclosporine reagent kit, list 1l75-55.After further evaluation, the suspect medical device was changed to architect cyclosporine reagent kit, list 1l75-25, lot number 37701fp00 ((b)(4) as manufacturing site), which is under this report.
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Manufacturer Narrative
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The complaint evaluation 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 in-house testing of architect cyclosporine reagent lot 37701fp00.The ticket search determined that there is normal complaint activity for the likely cause lot.Trending review determined no adverse trend for the issue for the product.Return testing was not completed as returns were not available.A specificity testing was performed on internal cyclosporine panels with a retained kit of lot 37701fp00.All validity and acceptance criteria were met during completion of the protocol, demonstrating that the lot is performing as expected.Device history record review did not identify any non-conformances or deviations with the complaint lot and complaint issue.A review of the manufacturing documentation did not identify any issues associated with the customer's observation.A review of the product labeling concluded that the issue is sufficiently addressed.Based on the investigation no product deficiency was identified for the architect cyclosporine reagent lot 37701fp00.
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Search Alerts/Recalls
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