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	09/10/2025
Type of Reportable Event	Malfunction
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.This report is being filed on an international product, list number 07p66, that has a similar product distributed in the us with the same list number, and a 510k/pma/bla number that¿s exempt.Cross reference emdr for ticket (b)(4).
Event or Problem Description
The customer observed falsely elevated alinity i prolactin results generated for a 9-year-old female patient who is not pregnant.The following data was provided: sample id 10276218 result = 110 ng/ml, result on siemens platform = 24 ng/ml.Sample was initially run at another laboratory on another alinity.Sample id (b)(6).Result = 110 ng/ml.No 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, device history record review, in house testing and labeling review.Data and information provided by the customer were reviewed and support the complaint issue without indication for any additional issue.Review of tracking and trending for the alinity i prolactin assay did not identify any trends related to the complaint issue.Additionally, no trends were identified for lot 73479ud00.In-house testing of a retained kit of lot 73479ud00 was completed.All specifications were met indicating the lot is performing acceptably.A device history record review did not identify any non-conformance or deviations associated with the complaint lot number and complaint issue.Labeling was reviewed which adequately addresses the current issue.Based on the investigation, no systemic issue or deficiency of the alinity i prolactin reagent lot 73479ud00 was identified.
Event or Problem Description
The customer observed falsely elevated alinity i prolactin results generated for a 9-year-old female patient who is not pregnant.The following data was provided: sample id (b)(6) result = 110 ng/ml, result on siemens platform = 24 ng/ml.Sample was initially run at another laboratory on another alinity.Sample id (b)(6) result = 110 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: 23144083
• Report Number: 3005094123-2025-00474
• Device Sequence Number: 9915932
• Product Code: CFT
• UDI-Device Identifier: 00380740121570
• UDI-Public: (01)00380740121570(17)260220(10)73479UD00
• Combination Product (Y/N): N
• Initial Reporter Country: GR
• 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): 12/24/2025

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: 02/20/2026
• Device Catalogue Number: 07P66-20
• Device Lot Number: 73479UD00
• 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: 09/15/2025
• Supplement Date Received by Manufacturer: 12/22/2025
• Initial Report FDA Received Date: 09/25/2025
• Supplement Report FDA Received Date: 12/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/13/2025
• 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).
• Patient Age: 9 YR
• Patient Sex: Female