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 02K91-78

Device Problem Low Test Results (2458)

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

Event Date 08/12/2021

Event Type  malfunction  

Manufacturer Narrative

This report is being filed on an international product, list number 02k91-78 has a similar product distributed in the us, list number 2k91-33.The complaint investigation for falsely depressed architect ca 19-9xr results included a search for similar complaints, and the review of complaint text, trending data, labeling, and device history records.Return testing was not completed as returns were not available.Trending review did not identify any trends for the issue for the product.Device history record review on lot 22003m800 did not show any non-conformances, potential non-conformances, or deviations.Labeling was reviewed and found to adequately address the issue under review.The historical performance of reagent lot 22003m800 was evaluated using worldwide data.Patient data was analyzed and compared to an established control limit.This evaluation indicated that the patient median result for lot 22003m800 is inside the established control limits, which indicates acceptable product performance.Based on the investigation no systemic issue or deficiency of the architect ca19-9xr for lot number 22003m800 was identified.

Event Description

The customer observed falsely depressed architect ca 19-9xr results for one patient diagnosed with cancer.It is unknown which cancer the patient has been diagnosed with.The following data was provided: initial result in august = 6232.92 u/ml, repeat result correlated.Result in july = 8.93 u/ml.No impact to patient management was reported.

• 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
• Manufacturer (Section G): ABBOTT GMBH; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• Manufacturer Contact: christian lee ; 100 abbott park road; dept. 09b9, lc cp01-3; abbott park, IL 60064-3537 ; 2246682940
• MDR Report Key: 12393502
• MDR Text Key: 277709859
• Report Number: 3002809144-2021-00539
• Device Sequence Number: 1
• Product Code: NIG
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K052000
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/31/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/06/2021
• Device Catalogue Number: 02K91-78
• Device Lot Number: 22003M800
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/17/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/09/2020
• 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