The customer observed a falsely decreased architect ca 19-9xr result for 1 patient who is diagnosed with pancreatic cancer.The following data was provided (reference range: 0 to 37 u/l): sid (b)(6) initial result = >1200 u/l, repeat with 1:10 autodilution = 166 u/l.Sample was repeat twice without a dilution = >1200 u/l for both runs, repeated twice with 1:10 autodilution = 1522 u/l and 1390 u/l.Previous ca19-9 result from november was high.No impact to patient management was reported.
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A review of tickets was performed for reagent lot number 05024m800.The ticket search determined that there is a normal complaint activity for the likely cause lot.Return testing was not completed as returns were not available.To further investigate the customer's issue, the historical performance of reagent lot 05024m800 was evaluated using world wide data.The patient data was analyzed and compared to an established control limit.This evaluation indicated that the patient median result for lot 05024m800 is not within the established control limits.Therefore, accuracy testing was performed for reagent lot 05024m800.The accuracy testing was performed using an internal architect ca 19-9 panel which was tested with a retained kit of the likely cause reagent lot.The testing failed for one replicate of panel 1 for one instrument therefore, a retest was performed on that panel and instrument.Acceptance criteria was met for the retest, which indicates acceptable product performance.A review of the manufacturing documentation did not identify any issues associated with the complaint issue.A review of labeling concluded that the issue is sufficiently addressed.Based on the investigation no systemic issue or deficiency of the architect ca 19-9xr for lot 05024m800 was identified.
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