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

Model Number	07P6220
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The customer observed discrepant alinity i cea results for a 77-year-old female patient.The following data was provided: july result (lot 36540fn00) = 120.4 ng/ml, august result (lot 36543fn00) = 25.58 ng/ml, september result (lot 39407fn00) = 79.6 ng/ml, october result (lot 39407fn00) = 22.9 ng/ml.No impact to patient management was reported.
Additional Manufacturer Narrative
An evaluation is in process.A final report will be submitted when the evaluation is complete.All available patient information was included.Additional patient details are not available. initial reporter name and address (b)(6).Initial reporter phone number: (b)(6).
Additional Manufacturer Narrative
The complaint investigation for discrepant (erratic/variable) alinity i cea (carcinoembryonic antigen) results 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 of a retained reagent kit.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 did not identify any non-conformances or deviations.The overall performance of alinity i cea (carcinoembryonic antigen) reagents in the field was reviewed using data from customers worldwide and suggested that the performance is acceptable and as expected.In-house retained reagent kits of the complaint lots were tested, and all specifications were met indicating that the lots are performing acceptably.Labeling was reviewed and found to adequately address the issue under review.No systemic issue or deficiency with the alinity i cea (carcinoembryonic antigen) reagent lots 36543fn00 were identified.

• Brand Name: ALINITY I CEA REAGENT KIT
• Common Device Name: SYSTEM, TEST, CARCINOEMBRYONIC ANTIGEN
• Manufacturer (Section D): ABBOTT IRELAND; finisklin business park; sligo F91VY 44; EI F91VY44
• Manufacturer (Section G): ABBOTT IRELAND; 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: 15687189
• Report Number: 3008344661-2022-00151
• Device Sequence Number: 7368060
• Product Code: DHX
• UDI-Device Identifier: 00380740130855
• UDI-Public: 00380740130855
• 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): 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): 01/11/2023

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: 07/31/2023
• Device Model Number: 07P6220
• Device Catalogue Number: 07P62-20
• Device Lot Number: 36543FN00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/06/2022
• Supplement Date Received by Manufacturer: 12/20/2022
• Initial Report FDA Received Date: 10/27/2022
• Supplement Report FDA Received Date: 01/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2022
• 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, AI20669; ALNTY I PROCESSING MODU, 03R65-01, AI20669
• Patient Age: 77 YR
• Patient Sex: Female