MAUDE Adverse Event Report: ABBOTT IRELAND DIAGNOSTICS DIVISION ARCHITECT PROLACTIN; RADIOIMMUNOASSAY, PROLACTIN (LACTOGEN)

Catalog Number	07K76-25
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/09/2026
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.
Event or Problem Description
The customer observed falsely depressed architect prolactin results for one female patient.The was repeated with higher results.The following data was provided: architect initial prolactin result processed on (b)(6) 2026 = <12.6 miu/l repeat result = 210 miu/l sample sent to another laboratory (method unknown) result = >200 miu/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, a search for similar complaints, a ticket trending review, a device history record review, field data review and a labeling review.Data and information provided by the customer were reviewed and support the complaint issue.A ticket search by lot indicates that the reagent lot performs as expected for this product.The trending review did not identify any trends for the issue for the product.The device history record review did not identify any non-conformances or deviations with lot number 74400ud00 and the complaint issue.Labeling was reviewed and sufficiently addresses the customer's issue.The overall performance of architect prolactin reagents in the field was reviewed using data gathered from customers worldwide.The patient median result for the complaint lot was analyzed and found to be comparable to all other lots in the field and confirms no systemic issue for the lot.Based on this investigation, no systemic issue or deficiency with the architect prolactin reagent, lot number 74400ud00, was identified.
Event or Problem Description
The customer observed falsely depressed architect prolactin results for one female patient.The was repeated with higher results.The following data was provided: architect initial prolactin result processed on (b)(6) 2026 = <12.6 miu/l repeat result = 210 miu/l sample sent to another laboratory (method unknown) result = >200 miu/ml no impact to patient management was reported.

• Brand Name: ARCHITECT PROLACTIN
• 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: 24110235
• Report Number: 3005094123-2026-00028
• Device Sequence Number: 5532342
• Product Code: CFT
• UDI-Device Identifier: 00380740014865
• UDI-Public: (01)00380740014865(17)260326(10)74400UD00
• Combination Product (Y/N): N
• Initial Reporter Country: RS
• 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
• Report Date (Section B): 03/19/2026

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: 03/26/2026
• Device Catalogue Number: 07K76-25
• Device Lot Number: 74400UD00
• 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: 01/12/2026
• Supplement Date Received by Manufacturer: 03/18/2026
• Initial Report FDA Received Date: 01/19/2026
• Supplement Report FDA Received Date: 03/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/14/2025
• 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: ARC I2000SR INST, 03M74-02, (B)(6).; ARC I2000SR INST, 03M74-02, (B)(6).
• Patient Sex: Female