MAUDE Adverse Event Report: ABBOTT IRELAND DIAGNOSTICS DIVISION ALINITY I PROLACTIN REAGENT KIT; RADIOIMMUNOASSAY, PROLACTIN (LACTOGEN)

Catalog Number	07P66-20
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/05/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Section a1 patient identifier complete information: (b)(6).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 falsely elevated alinity i prolactin results for one patient.The customer observed a difference between the plasma and serum sample results.The following results were provided: sid (b)(6) - heparinized plasma tube = 42.63 ng/ml sid (b)(6) ¿ serum tube = 26.19 ng/ml patient was drawn again with new sample sid (b)(6) - serum = 23.75 ng/ml no impact to patient management was reported.
Additional Manufacturer Narrative
The complaint investigation for false elevated alinity i prolactin 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.Data and information provided by the customer were reviewed and support the complaint issue.Review of tracking and trending for the alinity i prolactin assay did not identify an increase in complaint activity related to the complaint issue.Additionally, an increase in complaint activity was not identified for reagent lot 70308ud00.The device history record review did not identify any nonconformances, potential nonconformances or deviations associated with the lot number and complaint issue.In house accuracy testing was completed with a retained kit of the complaint lot.All validity and acceptance criteria were met during completion of the protocol, demonstrating that the lot is performing as expected.Labeling was reviewed and adequately addresses the issue.The customer used a plasma separator gel tube for the plasma sample, which is not verified for use with this assay per the package insert.Based on the investigation, the device met performance specification and performed as intended at the customer site, therefore there is no systemic issue or deficiency with the alinity i prolactin lot 70308ud00.All available patient information was included.Additional patient details are not available.
Event or Problem Description
The customer observed falsely elevated alinity i prolactin results for one patient.The customer observed a difference between the plasma and serum sample results.The following results were provided: sid (b)(6) - heparinized plasma tube = 42.63 ng/ml.Sid (b)(6) ¿ serum tube = 26.19 ng/ml.Patient was drawn again with new sample sid (b)(6) - serum = 23.75 ng/ml.No impact to patient management was reported.

• Brand Name: ALINITY I PROLACTIN REAGENT KIT
• Common Device Name: RADIOIMMUNOASSAY, PROLACTIN (LACTOGEN)
• Manufacturer (Section D): ABBOTT IRELAND DIAGNOSTICS DIVISION; lisnamuck; co. longford; longford N39E9 32; EI N39E932
• Manufacturer (Section G): ABBOTT IRELAND DIAGNOSTICS DIVISION; lisnamuck; co. longford; longford N39E9 32; EI N39E932
• Manufacturer Contact: nicole jenne ; max-planck-ring 2; post market surveillance; wiesbaden 65205 ; GM 65205 ; 6122582960
• MDR Report Key: 22124807
• Report Number: 3005094123-2025-00271
• Device Sequence Number: 8683465
• Product Code: CFT
• UDI-Device Identifier: 00380740121570
• UDI-Public: (01)00380740121570(17)251025(10)70308UD00
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• 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): 09/10/2025

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: 10/25/2025
• Device Catalogue Number: 07P66-20
• Device Lot Number: 70308UD00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/21/2025
• Supplement Date Received by Manufacturer: 09/08/2025
• Initial Report FDA Received Date: 06/02/2025
• Supplement Report FDA Received Date: 09/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/28/2024
• 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
• Patient Sex: Unknown