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

Catalog Number 02K91-38

Device Problem High Test Results (2457)

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

Event Date 11/12/2018

Event Type  malfunction  

Manufacturer Narrative

An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.This report is being filed on an international product, architect ca 19-9 (list 02k91-38), that has a similar product in the us (list 02k91-29 and 02k91-33), which is manufactured in abbott park, il usa.

Event Description

The customer observed a falsely elevated undiluted architect ca19-9xr result of >1200 u/ml for sample id (b)(4).After automatic 1:10 dilution the results were 275.3, 233.2, and 259.71.After manual dilution at 1:2, 1:4, 1:8, 1:16 were, respectively: 867.2, 431.6, 305.6, 252.8.The customer suspects an interference in the sample.No impact to patient management reported.

Manufacturer Narrative

Udi # = (b)(4); lot # = 88015m800.This report is being filed on an international product, architect ca 19-9 (list 02k91-38), that has a similar product in the us (list 02k91-29 and 02k91-33), which is manufactured in (b)(4).The customers instrument logs were reviewed and did not identify conclusive information to indicate an instrument or sample integrity issue.Review of complaint activity determined that there was normal complaint activity for the likely cause lot 88015m800.Tracking and trending report review for the architect ca 19-9xr assay determined that there were no related adverse or non-statistical trends.Using worldwide field data the performance of reagent lot 88015m800 was evaluated.The median result is within the established control limits.Labeling was reviewed and sufficiently addresses the customer's issue.No systemic issue or deficiency of the architect ca19-9 xr assay was identified.

Manufacturer Narrative

An error was identified on 16jan2019.This report was filed against the incorrect manufacturing site.Manufacturer report 3002809144-2019-00021 has been submitted to correct this, and all follow up information will be provided in that report.

• Brand Name: ARCHITECT CA 19-9XR
• Type of Device: CA 19-9
• Manufacturer (Section D): ABBOTT LABORATORIES; 100 abbott park road; abbott park IL 60064 3500
• MDR Report Key: 8110493
• MDR Text Key: 129352152
• Report Number: 1415939-2018-00161
• Device Sequence Number: 1
• Product Code: NIG
• Combination Product (y/n): N
• PMA/PMN Number: K052000
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 01/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/28/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/12/2019
• Device Catalogue Number: 02K91-38
• Device Lot Number: 88015M800
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARCHITECT I2000SR, LIST 03M74-02; ARCHITECT I2000SR, LIST 03M74-02; SERIAL (B)(4) ; SERIAL (B)(4)