MAUDE Adverse Event Report: ABBOTT GMBH ARCHITECT CA19-9XR REAGENT KIT; SYSTEM, TEST, CARBOHYDRATE AG (CA19-9), FOR MONIT AND MGMT OF PANCREATIC CANCER

Catalog Number 02K91-39

Device Problem High Test Results (2457)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/03/2021

Event Type  malfunction  

Manufacturer Narrative

An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.All available patient information was included.Additional patient details are not available.This report is being filed on an international product, list number 02k91-39, that has a similar product distributed in the us, list number 02k91-33.

Event Description

The customer observed a falsely elevated architect ca 19-9xr result for an (b)(6) year-old male patient.The following data was provided (customer¿s reference range is <37.0 u/ml): initial result was >1200 u/ml, automatic 1:2 dilution was 1259, 1:4 was 430, 1:5 was 259 and 1:10 was 96.7 and 98.0 u/ml.The sample was manually diluted, 1:20 was 67.46 u/ml and 1:40 was 37.6 u/ml.Cea results, which were not being questioned by the customer, were 3.38 ng/ml.There was no impact to patient management reported.

Manufacturer Narrative

The complaint investigation for falsely elevated architect ca 19-9xr results included a search for similar complaints, and the review of complaint text, trending data, labeling, device history records, and historical performance of reagent lot 24026m800, through abbottlink data.Trending review determined no related trend for the issue for the product.The historical performance of reagent lot 24026m800 was evaluated using worldwide data from abbottlink.Patient data was analyzed and compared to an established control limit.This evaluation indicated that the patient median result for lot 24026m800 is inside the established control limits, which indicates acceptable product performance.Device history record review did not identify any non-conformances or deviations with the likely cause lot and complaint issue.Manufacturing documentation for the likely cause lot was reviewed and did not identify any issues.Labeling was reviewed and sufficiently addresses the customer's issue.Based on the information provided and abbott diagnostics¿ complaint investigation, no systemic issue or deficiency of architect ca 19-9xr, lot number 24026m800, was identified.

• Brand Name: ARCHITECT CA19-9XR REAGENT KIT
• Type of Device: SYSTEM, TEST, CARBOHYDRATE AG (CA19-9), FOR MONIT AND MGMT OF PANCREATIC CANCER
• Manufacturer (Section D): ABBOTT GMBH; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• MDR Report Key: 12527104
• MDR Text Key: 277994866
• Report Number: 3002809144-2021-00580
• 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
• Report Date: 10/27/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 01/08/2022
• Device Catalogue Number: 02K91-39
• Device Lot Number: 24026M800
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/04/2021
• Initial Date FDA Received: 09/24/2021
• Supplement Dates Manufacturer Received: 10/18/2021
• Supplement Dates FDA Received: 10/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARC I2K PROC MOD, 03M74-01, (B)(6).; ARC I2K PROC MOD, 03M74-01, (B)(6).
• Patient Age: 85 YR