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 ca19-9 list 02k91-39, that has a similar product distributed in the us, list number 02k91-29 and 02k91-33.This event is also being reported in mfg report 3002809144-2018-00523, for a second suspect medical device (list 02k91-39, lot 82032m800).
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The customer observed a falsely elevated architect ca19-9xr result of 3862 u/ml during monitoring of a pancreatic cancer patient (sid: (b)(6)).The patient had previously undergone surgery after which ca19-9 had decreased to 137 u/ml ((b)(6) 2018).On (b)(6) 2018 and (b)(6) 2018, ca19-9 results were 2914 and 3522, respectively.Pet/ct scans did not show any findings of recurrence.No impact to patient management was reported.
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An investigation was performed by reviewing the complaint text, service history, tracking and trending metrics, and the current labeling for the architect ca-19-9xr package insert.A review of the product labeling concluded that the issue is sufficiently addressed.No trend associated with the architect ca 19-9xr discrepant results.No product deficiency was identified.
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