MAUDE Adverse Event Report: ABBOTT IRELAND DIAGNOSTICS DIVISION ALINITY I CEA REAGENT KIT; SYSTEM, TEST, CARCINOEMBRYONIC ANTIGEN

Catalog Number	07P62-30
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/08/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The customer observed a falsely elevated alinity i cea result on one 63 year old male patient diagnosed with asthma/copd/pulmonary fibrosis/history of smoking.The patient has not been diagnosed with cancer.The following data was provided: alinity result processed on (b)(6) 2024 = 46.31 ng/ml historical results: (b)(6) 2024 = 40.9 ng/ml (b)(6) 2024 = 31.4 ng/ml (b)(6) 2021 = 16.8 ng/ml the customer reported that a chest/abdominal ct scan(without contrast) and a upper/lower digestive endoscopy was performed due to the falsely elevated alinity i cea result of 40.9 ng/ml, but no malignant tumor was found.The customer stated there was no harm to the patient.No further impact to patient management was reported.
Additional Manufacturer Narrative
An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Event or Problem Description
The customer observed a falsely elevated alinity i cea result on one 63-year-old male patient diagnosed with asthma/copd/pulmonary fibrosis/history of smoking.The patient has not been diagnosed with cancer.The following data was provided: alinity result processed on (b)(6) 2024 = 46.31 ng/ml.Historical results: (b)(6) 2024 = 40.9 ng/ml.(b)(6) 2024 = 31.4 ng/ml.(b)(6) 2021 = 16.8 ng/ml.The customer reported that a chest/abdominal ct scan (without contrast) and a upper/lower digestive endoscopy was performed due to the falsely elevated alinity i cea result, but no malignant tumor was found.The customer stated there was no harm to the patient.No further impact to patient management was reported.
Additional Manufacturer Narrative
The complaint investigation included a review of data and information provided by the customer, search for similar complaints, ticket trending review, labeling review, device history record review, and in-house testing.Return testing was not completed as returns were not available.Data and information provided by the customer were reviewed and support the complaint issue without indication for any additional issue.A ticket search by lot did not identify an increase in complaint activity.A review of ticket trending did not identify any trends regarding commonalities for the lot number 54280fn00 and complaint issue.Accuracy testing was performed and met acceptance criteria and the product is performing as expected.A review of data history records did not identify any non-conformances or deviations associated with the lot number 54280fn00 and complaint issue.Labeling was reviewed and adequately addresses the issue.Based on the investigation, the device met performance specifications and performed as intended at the customer site, therefore, no systemic issue or deficiency of the alinity i cea reagent kit, lot 54280fn00 was identified.

• Brand Name: ALINITY I CEA REAGENT KIT
• Common Device Name: SYSTEM, TEST, CARCINOEMBRYONIC ANTIGEN
• Manufacturer (Section D): ABBOTT IRELAND DIAGNOSTICS DIVISION; finisklin business park; sligo F91VY 44; EI F91VY44
• Manufacturer (Section G): ABBOTT IRELAND DIAGNOSTICS DIVISION; finisklin business park; sligo F91VY 44; EI F91VY44
• Manufacturer Contact: nicole jenne ; max-planck-ring 2; post market surveillance; wiesbaden 65205 ; GM 65205 ; 6122582960
• MDR Report Key: 19547939
• Report Number: 3008344661-2024-00071
• Device Sequence Number: 20534689
• Product Code: DHX
• UDI-Device Identifier: 00380740130862
• UDI-Public: (01)00380740130862(17)241228(10)54280FN00
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K990774
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/24/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/28/2024
• Device Catalogue Number: 07P62-30
• Device Lot Number: 54280FN00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/12/2024
• Supplement Date Received by Manufacturer: 07/24/2024
• Initial Report FDA Received Date: 06/17/2024
• Supplement Report FDA Received Date: 07/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/19/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ALNTY I PROCESSING MODU, 03R65-01, (B)(6) ; ALNTY I PROCESSING MODU, 03R65-01, (B)(6)
• Outcome Attributed to Adverse Event: Other
• Patient Age: 63 YR
• Patient Sex: Male