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	07/01/2025
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 reported a falsely elevated alinity i prolactin result on a patient.Results provided: on (b)(6) 2025, sid (b)(6) (62-yr old male) = >27.09, history of prolactin of 5.80 ng/ml; another laboratory chemiluminescence platform = 9.6 ng/ml, normal range male: 3.46-19.40 ng/ml, no impact to patient management was reported.
Additional Manufacturer Narrative
Data and information provided by the customer were reviewed and support the complaint issue.A search for similar complaints did not identify an increase in trends for calibrator lot 72065ud00, but a search for similar complaints for lot 72165ud00 did identify an increase in complaint activity.However, a review of tracking and trending for the alinity i prolactin assay did not identify any trends related to the complaint issue.A device history record review did not identify issues associated with the customer¿s observation.The overall performance of alinity i prolactin reagents in the field was reviewed using data from customers worldwide.The review shows that the median patient result for the master lot falls within +/-2sd of the established baseline, indicating the reagent lot is performing acceptably.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 72165ud00 was identified.
Event or Problem Description
The customer reported a falsely elevated alinity i prolactin result on a patient.Results provided: (b)(6) 2025 sid (b)(6) (62-yr old male) = >27.09, history of prolactin of 5.80 ng/ml; another laboratory chemiluminescence platform = 9.6 ng/ml.Normal range male: 3.46-19.40 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: 23579746
• Report Number: 3005094123-2025-00580
• Device Sequence Number: 9304932
• Product Code: CFT
• UDI-Device Identifier: 00380740121570
• UDI-Public: (01)00380740121570(17)260108(10)72165UD00
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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): 02/20/2026

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: 01/08/2026
• Device Catalogue Number: 07P66-20
• Device Lot Number: 72165UD00
• 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: 10/31/2025
• Supplement Date Received by Manufacturer: 02/12/2026
• Initial Report FDA Received Date: 11/18/2025
• Supplement Report FDA Received Date: 02/20/2026
• 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).; ALNTY I PROLACTIN CAL K, 07P66-01, 72065UD00.
• Patient Age: 62 YR
• Patient Sex: Male