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	08/22/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported falsely elevated alinity i prolactin.The customer initially reported elevated qc and then reported an elevated patient result.The customer provided the following data: the prolactin result was 68 ng/ml., and when tested at another facility with the roche platform, the result was 27 ng/ml.There was no reported impact on patient management.
Additional Manufacturer Narrative
An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Additional Manufacturer Narrative
Additional information can be found in sections a1 patient identifier and b5 describe event or problem.
Event or Problem Description
The customer reported falsely elevated alinity i prolactin.The customer initially reported elevated qc and then reported an elevated patient result.The customer provided the following data: the prolactin result was 68 ng/ml., and when tested at another facility with the roche platform, the result was 27 ng/ml.There was no reported impact on patient management.Update: the customer provided the following sample id: (b)(4).
Additional Manufacturer Narrative
The data and information provided by the customer were reviewed and supported the complaint issue without indication of any additional issues.A ticket search by lot indicates that the reagent lot 71151ud00 performs as expected for this product.A review of tracking and trending for the alinity i prolactin assay did not identify any related trends related to the complaint issue.A review of the device history record did not identify any non-conformances, potential non-conformance or deviations with the complaint lot and complaint issue.Accuracy testing was completed utilizing an in-house retained reagent kit of the complaint lot.All specifications were met indicating that the lot is performing as expected.A review of labeling was performed and found to sufficiently address the customer's issue.Based on this investigation, no systemic issue or deficiency was identified with the alinity i prolactin reagent, lot number 71151ud00.
Event or Problem Description
The customer reported falsely elevated alinity i prolactin.The customer initially reported elevated qc and then reported an elevated patient result.The customer provided the following data: the prolactin result was 68 ng/ml., and when tested at another facility with the roche platform, the result was 27 ng/ml.There was no reported impact on patient management.Update: the customer provided the following sample id: (b)(6).

• 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: 22968371
• Report Number: 3005094123-2025-00428
• Device Sequence Number: 9257849
• Product Code: CFT
• UDI-Device Identifier: 00380740121570
• UDI-Public: (01)00380740121570(17)251204(10)71151UD00
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/01/2025

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: 12/04/2025
• Device Catalogue Number: 07P66-20
• Device Lot Number: 71151UD00
• 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: 08/22/2025
• Supplement Date Received by Manufacturer: 10/28/2025; 11/26/2025
• Initial Report FDA Received Date: 09/04/2025
• Supplement Report FDA Received Date: 10/30/2025; 12/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/13/2025
• 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 PROCESSING MODU, 03R65-01, (B)(6).
• Patient Sex: Unknown