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

Catalog Number	07P66-30
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/18/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer observed falsely depressed alinty i prolactin results for two patients.The following results were provided: all initial prolactin results listed are from on (b)(6) 2025.Prolactin (prolactin result units: ng/ml, reference value: male: 3.46-19.40, female: 5.18-26.53) sid: (b)(6), male, initial prolactin result 9.45 ng/ml, repeated on another machine 17.87 ng/ml, repeated after new calibration 19.93 ng/ml.Sid: (b)(6), female, initial prolactin result 18.31 ng/ml, repeated on another machine 33.26 ng/ml, repeated after new calibration 35.58 ng/ml.No impact to patient management was reported.
Additional Manufacturer Narrative
Complete entry for section a1: patient identifier: (b)(6).Complete entry for section a3a: sex: male and female.Complete entry for section e1: phone number: (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.
Additional Manufacturer Narrative
Data and information provided by the customer were reviewed and support the complaint issue.Review of tracking and trending for the alinity i prolactin calibrator did not identify any trends related to the complaint issue.Additionally, no trends were identified for lot 72065ud00.Device history review did not identify issues associated with the customer¿s observation.In-house accuracy testing was completed using panels which mimic patient samples using an in-house retained kit of lot 72065ud00.All specifications were met indicating that the 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 calibrator lot number 72065ud00 using reagent lot 73476ud00 was identified.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.
Event or Problem Description
The customer observed falsely depressed alinty i prolactin results for two patients.The following results were provided: all initial prolactin results listed are from (b)(6) 2025.Prolactin (prolactin result units: ng/ml, reference value: male: 3.46-19.40, female: 5.18-26.53) sid (b)(6), male, initial prolactin result 9.45 ng/ml, repeated on another machine 17.87 ng/ml, repeated after new calibration 19.93 ng/ml.Sid (b)(6), female, initial prolactin result 18.31 ng/ml, repeated on another machine 33.26 ng/ml, repeated after new calibration 35.58 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: 23220664
• Report Number: 3005094123-2025-00500
• Device Sequence Number: 8780706
• Product Code: CFT
• UDI-Device Identifier: 00380740121587
• UDI-Public: (01)00380740121587(17)260220(10)73476UD00
• 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): 01/22/2026

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: 02/20/2026
• Device Catalogue Number: 07P66-30
• Device Lot Number: 73476UD00
• 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: 09/19/2025
• Supplement Date Received by Manufacturer: 01/21/2026
• Initial Report FDA Received Date: 10/06/2025
• Supplement Report FDA Received Date: 01/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/19/2025
• 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 Sex: Male