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

Catalog Number	02K91-39
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
All available patient information was included.An evaluation is in process.A final report will be submitted when the evaluation is complete.This report is being filed on an international product, architect ca19-9 list (b)(4) that has a similar product distributed in the us, list number (b)(4).
Event or Problem Description
The following data was provided from the architect sid (b)(6) initial 1865.3 u/ml.Which was compared to a result from another method: 500 u/ml.There is no information on the patients clinical history.There was no impact to patient management reported.
Additional Manufacturer Narrative
Further investigation of the customer issue included a review of the complaint text, a search for similar complaints, review of field data, and a review of labeling.No adverse trend was identified for the customer's issue.No return patient sample was available.Historical performance of the reagent lot was evaluated using world wide data.The patient data was analyzed and within established control limits.Labeling was reviewed and found to be adequate.Based on all available information and abbott diagnostics' complaint investigation no product deficiency was identified.

• Brand Name: ARCHITECT CA 19-9XR
• Common Device Name: CA 19-9
• Manufacturer (Section D): ABBOTT GERMANY; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• MDR Report Key: 7638655
• Report Number: 3002809144-2018-00073
• Device Sequence Number: 16764723
• Product Code: NIG
• UDI-Device Identifier: 00380740137304
• UDI-Public: 00380740137304
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K052000
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/06/2018

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: 11/13/2018
• Device Catalogue Number: 02K91-39
• Device Lot Number: 82031M800
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 06/04/2018
• Supplement Date Received by Manufacturer: 06/29/2018
• Initial Report FDA Received Date: 06/26/2018
• Supplement Report FDA Received Date: 07/06/2018
• 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 I2000SR ANALYZER; ARCHITECT I2000SR ANALYZER; LN 03M74-01 SN (B)(4); LN 03M74-01 SN (B)(4)