MAUDE Adverse Event Report: ABBOTT GMBH ALINITY I CA 19-9XR REAGENT KIT; SYSTEM, TEST, CARBOHYDRATE AG (CA19-9), FOR MONIT AND MGMT OF PANCREATIC CANCER

Catalog Number 08P32-77

Device Problem High Test Results (2457)

Patient Problem Insufficient Information (4580)

Event Date 02/22/2021

Event Type  Injury  

Manufacturer Narrative

Was this device serviced by a third party? no.This report is being filed on an international product, list number 08p32-77 that has a similar product distributed in the us, list number 8p32-21 / 31.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Event Description

The customer reported falsely elevated alinity i ca 19-9xr results and a discrepancy between the undiluted and diluted ca 19-9xr results on a (b)(6) year-old female patient who had a colonoscopy in (b)(6) 2021 and was diagnosed with a colon polyp.It is unclear if the colonoscopy was performed specifically due to the elevated ca 19-9xr results.The patient had a history of intestinal dysfunction, gastroesophageal reflux, elevated ca19-9 results, and was previously pregnant but on (b)(6) 2021 it was reported that the patient was no longer pregnant.The patient expressed a state of non-pregnancy at the time of the colonoscopy.The patient has not been diagnosed with pancreatic cancer.The alinity i ca 19-9xr result on (b)(6) 2021 was >(b)(6) u/ml, which was consistent with the patient¿s previous results ((b)(6) 2020 ca 19-9 result was (b)(6) u/ml, (b)(6) 2021 ca 19-9 result was (b)(6) u/ml) (customer¿s reference range 0 to 37 u/ml).The sample from (b)(6) 2021 was retested with dilution and the results were also elevated: (b)(6).Additionally, the roche result at another hospital was 137.6 (no unit of measure provided).The patient underwent a colonoscopy and was diagnosed with a colon polyp.

Manufacturer Narrative

The complaint investigation included a search for similar complaints, the review of complaint text, trending data, labeling, device history records, and accuracy testing of reagent lot 23909fp00.A cross functional team (cft) reviewed the complaint and determined the adverse event was due to incorrect use of the assay since the decision to perform a colonoscopy was based on the elevated alinity i ca 19-9xr result.Alinity i ca 19-9xr testing was performed on one patient that does not have pancreatic cancer.The patient had falsely elevated alinity i ca 19-9xr results and results were also being compared to results obtained with another method.Since the patient does not have pancreatic cancer, the assay is not being used per the intended use of monitoring for pancreatic cancer.Additionally, the role of ca 19-9 is to be used as an adjunct with other diagnostic information in the management of patients with pancreatic cancer.No data exist to support the use of ca 19-9 in screening for malignancies.Return testing was not completed as returns were not available.A ticket search for lot 23909fp00 did not identify increased complaint activity related to the issue under review.A review of tracking and trending did not identify any trends for the complaint issue.Device history record review did not identify any issues associated with the product and the complaint issue.Accuracy testing was performed to evaluate the performance of reagent lot 23909fp00.Internal panels were tested with a retained kit of the likely cause reagent lot.Acceptance criteria were met, which indicates acceptable product performance.Additionally, labeling was reviewed and found to adequately address the issue under review.Based on the investigation, no deficiency of the alinity i ca19-9xr reagent lot number 23909fp00 was identified.This follow up is being submitted to include d8 and h6 information previously submitted using the h10 section in their respective fields.

• Brand Name: ALINITY I CA 19-9XR 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: 11509452
• MDR Text Key: 244396091
• Report Number: 3002809144-2021-00174
• Device Sequence Number: 1
• Product Code: NIG
• Combination Product (y/n): N
• 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: 05/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/06/2021
• Device Catalogue Number: 08P32-77
• Device Lot Number: 23909FP00
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ALNTY I PROCESSING MODU, 03R65-01, AI04189; ALNTY I PROCESSING MODU, 03R65-01, AI04189
• Patient Outcome(s): Disability
• Patient Age: 36 YR