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	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/10/2023
Type of Reportable Event	Malfunction
Additional 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.
Event or Problem Description
The customer observed a falsely decreased alinity i cea result for a cancer patient.The following data was provided: sample id 406218372 initial result, on (b)(6) 2023, was <2 ug/l.The patient was redrawn and tested on (b)(6) 2023, and the result was 381 ug/l.The patient was redrawn and tested on (b)(6) 2023, and the result was 321 ug/l.The patient¿s previous result, on (b)(6) 2023, was 193 ug/l.There was no impact to patient management reported.
Additional Manufacturer Narrative
The complaint investigation for a falsely decreased alinity i cea result 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 testing of the complaint lot.Trending review determined no related trend for the product.Manufacturing documentation for the likely cause lot was reviewed and did not identify any issues.Device history record review on lot number 42723fn00 did not identify any non-conformances or deviations with the likely cause lot.Accuracy testing was performed using panels, which mimics patient samples, and an in-house retained kit of lot 42723fn00, stored at the recommended storage condition.All specifications were met indicating that the lot is performing acceptably.Based on the information provided and abbott diagnostics¿ complaint investigation, no systemic issue or deficiency of alinity i cea, lot number 42723fn00, was identified.
Event or Problem Description
The customer observed a falsely decreased alinity i cea result for a cancer patient.The following data was provided: sample id (b)(6) initial result, on 10jul, was <2 ug/l.The patient was redrawn and tested on 24jul2023, and the result was 381 ug/l.The patient was redrawn and tested on 31jul2023, and the result was 321 ug/l.The patient¿s previous result, on 02jul2023, was 193 ug/l.There was no impact to patient management reported.

• 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: siobhan wright ; lisnamuck; post market surveillance; longford N39 E-932 ; EI N39 E932 ; 433331157
• MDR Report Key: 17560295
• Report Number: 3008344661-2023-00155
• Device Sequence Number: 11669215
• Product Code: DHX
• UDI-Device Identifier: 00380740130862
• UDI-Public: 00380740130862
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K990774
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/13/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/11/2024
• Device Catalogue Number: 07P62-30
• Device Lot Number: 42723FN00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/31/2023
• Supplement Date Received by Manufacturer: 09/05/2023
• Initial Report FDA Received Date: 08/16/2023
• Supplement Report FDA Received Date: 09/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/08/2022
• 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, AI03752; ALNTY I PROCESSING MODU, 03R65-01, AI03752
• Patient Sex: Unknown