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

Catalog Number 02K91-32

Device Problem High Test Results (2457)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

This report is being filed on an international product, list number 02k91-32 that has a similar product distributed in the us, list number 02k91-33.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.An evaluation is in-process.

Event Description

The customer observed a falsely elevated ca19-9 result while using the architect ca19-9xr assay.The customer provided the following data (u/ml): initial test: 331, retests 5.31 and 8.26.There was no adverse impact to patient management reported.

Manufacturer Narrative

Evaluation of the customer issue included a review of the complaint text, a lot review, a design history record (dhr) review, a search for similar complaints, and a review of labeling.Return material was not available.Historical performance of reagent lot 74020m800 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 74020m800 is within the established control limits.Therefore, no unusual reagent lot performance was identified for lot 74020m800.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 74020m800, was identified.

• Brand Name: ARCHITECT CA 19-9XR
• Type of Device: CA 19-9
• Manufacturer (Section D): ABBOTT GERMANY; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• Manufacturer (Section G): ABBOTT GERMANY; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• Manufacturer Contact: noemi romero-kondos, rn bsn ; 100 abbott park road; dept. 09b9, lccp1-3; abbott park, IL 60064-3537 ; 224667-512
• MDR Report Key: 7138154
• MDR Text Key: 96009115
• Report Number: 3002809144-2017-00168
• Device Sequence Number: 1
• Product Code: NIG
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 01/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/16/2018
• Device Catalogue Number: 02K91-32
• Device Lot Number: 74020M800
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/09/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1