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

Catalog Number	02K91-38
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/09/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report is being filed on an international product, list number 02k91-38 that has a similar product distributed in the us, list number 02k91-33.(b)(6).Evaluation of the customer issue included a review of the complaint text, field data review, a design history record (dhr) review, a search for similar complaints, and a review of labeling.Return material was not available.An analysis utilizing customer field data was used to assess the specificity of the assay.Instrument data analytics (ida) reports for the architect ca19-9xr assay were reviewed to determine if the median patient values have shifted over time.The analysis concluded that the reagent lot read patient results consistently therefore determined the reagent is performing acceptably.The dhr review did not identify any potential non-conformances, non-conformances or deviations related to the complaint issue.Tracking and trending did not identify an adverse trend.Labeling was reviewed and found to be adequate.Based on the available information no product deficiency of the architect ca19-9xr reagent, list number 02k91, lot 91003m800 was identified.
Event or Problem Description
The customer observed falsely elevated ca19-9 results while using the architect ca19-9xr assay.The customer provided the following results: on (b)(6) 2019: sid (b)(6): initial: 251.66 u/ml, retest: 3.6 u/ml.There was no adverse impact to patient management reported.

• 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: 8570272
• Report Number: 3002809144-2019-00262
• Device Sequence Number: 19265473
• Product Code: NIG
• UDI-Device Identifier: 00380740137304
• UDI-Public: 00380740137304
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/01/2019

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: 08/16/2019
• Device Catalogue Number: 02K91-38
• Device Lot Number: 91003M800
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/09/2019
• Initial Report FDA Received Date: 05/01/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1