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

Catalog Number 02K91-38

Device Problem High Test Results (2457)

Patient Problem Test Result (2695)

Event Date 10/12/2018

Event Type  Injury  

Manufacturer Narrative

This report is being filed on an international product, architect ca19-9, list 02k91-38 that has a similar product distributed in the us, list 02k91-29 and 02k91-33, which is manufactured in (b)(4) usa.

Event Description

The account generated a false elevated patient result when using.Architect ca19-9xr.Initial result >1200 u/ml.Repeat result >1200 u/ml and 2445 u/ml (after dilution of instrument).The customer also tested using a beckman platform and the result was 18 u/ml.Architect quality controls and calibrations were normal.As a result of the false elevated results, the patient underwent an ultrasound and gastroscopy, with no abnormalities found.

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 (intended use section of the architect ca 19-9xr reagent package insert which states that the architect ca 19-9xr assay is to be used as an aid in the management of pancreatic cancer patients in conjunction with other clinical methods).Based on all available information and abbott diagnostics' complaint investigation no product deficiency was identified.

Manufacturer Narrative

An error was identified on jan 16, 2019.This report was filed against the incorrect manufacturing site.Manufacturer report 3002809144-2019-00020 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: 8035013
• MDR Text Key: 126015111
• Report Number: 1415939-2018-00156
• 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: 11/02/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/16/2019
• Device Catalogue Number: 02K91-38
• Device Lot Number: 87015M800
• 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; ARCHITECT I2000SR, LIST 03M74-02; SERIAL (B)(4); SERIAL (B)(4); SERIAL (B)(4); ARCHITECT I2000SR, LIST 03M74-02; SERIAL (B)(4)
• Patient Outcome(s): Other
• Patient Age: 49 YR