MAUDE Adverse Event Report: ABBOTT GMBH ARCHITECT CA 19-9XR

Model Number	2K91-33
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/11/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient information: no further patient information was provided by the customer.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Event or Problem Description
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.
Additional Manufacturer Narrative
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.

• Brand Name: ARCHITECT CA 19-9XR
• Common Device Name: CA 19-9
• Manufacturer (Section D): ABBOTT GMBH; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• MDR Report Key: 9526086
• Report Number: 3002809144-2019-01092
• Device Sequence Number: 14129130
• Product Code: NIG
• UDI-Device Identifier: 00380740137304
• UDI-Public: 00380740137304
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K052000
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/03/2020
• Device Model Number: 2K91-33
• Device Catalogue Number: 02K91-33
• Device Lot Number: 05024M800
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/11/2019
• Supplement Date Received by Manufacturer: 03/06/2020
• Initial Report FDA Received Date: 12/27/2019
• Supplement Report FDA Received Date: 03/12/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ARCHITECT I1000SR PROCESSING MODULE; ARCHITECT I1000SR PROCESSING MODULE; LIST 01L86-01, SERIAL (B)(4); LIST 01L86-01,SERIAL (B)(4)