Catalog Number 02K91-38 |
Device Problem
High Test Results (2457)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 11/12/2018 |
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.This report is being filed on an international product, architect ca 19-9 (list 02k91-38), that has a similar product in the us (list 02k91-29 and 02k91-33), which is manufactured in abbott park, il usa.
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Event Description
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The customer observed a falsely elevated undiluted architect ca19-9xr result of >1200 u/ml for sample id (b)(4).After automatic 1:10 dilution the results were 275.3, 233.2, and 259.71.After manual dilution at 1:2, 1:4, 1:8, 1:16 were, respectively: 867.2, 431.6, 305.6, 252.8.The customer suspects an interference in the sample.No impact to patient management reported.
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Manufacturer Narrative
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Udi # = (b)(4); lot # = 88015m800.This report is being filed on an international product, architect ca 19-9 (list 02k91-38), that has a similar product in the us (list 02k91-29 and 02k91-33), which is manufactured in (b)(4).The customers instrument logs were reviewed and did not identify conclusive information to indicate an instrument or sample integrity issue.Review of complaint activity determined that there was normal complaint activity for the likely cause lot 88015m800.Tracking and trending report review for the architect ca 19-9xr assay determined that there were no related adverse or non-statistical trends.Using worldwide field data the performance of reagent lot 88015m800 was evaluated.The median result is within the established control limits.Labeling was reviewed and sufficiently addresses the customer's issue.No systemic issue or deficiency of the architect ca19-9 xr assay was identified.
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Manufacturer Narrative
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An error was identified on 16jan2019.This report was filed against the incorrect manufacturing site.Manufacturer report 3002809144-2019-00021 has been submitted to correct this, and all follow up information will be provided in that report.
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Search Alerts/Recalls
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