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

Catalog Number	07K76-25
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/26/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported falsely elevated architect prolactin results generated by the alinity i processing module for two female patients.These results were inconsistent with the results produced by other platforms.The following data were provided: customer¿s normal range for women: 5.18 to 26.53 ng/ml.Patient 1 (42-year-old): sample id: (b)(6) first blood draw: architect prolactin result = 27 ng/ml, roche platform result = 13 ng/ml and 13 ng/ml.(b)(6) 2025 (second blood draw): architect prolactin result = 22.91 ng/ml chemiluminescence method = 13 ng/ml.Patient¿s historical result = 44 ng/ml.Patient 2 (47-year-old): sample id: (b)(6) on (b)(6) 2025 (first blood draw): architect prolactin result = 47.39 ng/ml roche platform result = 16 ng/ml.On (b)(6) 2025 (second blood draw): architect prolactin result = 48.42 ng/ml, chemiluminescence method = 13 ng/ml, maglumi platform result = 15 ng/ml.Patient¿s historical result = 44 ng/ml no impact to patient management was reported.
Additional Manufacturer Narrative
An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.Section a patient information: refer to section b5 for complete patient information.All available patient information were included; no additional patient information was available.
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 search for similar complaints did not identify an increase in complaint activity for lot 74400ud00.A review of tracking and trending for the architect prolactin assay did not identify any trends related to the complaint issue.A review of the device history record did not identify any non-conformances, potential non-conformances or deviations with lot number 74400ud00 and the complaint issue.The overall performance of the architect prolactin reagent was reviewed using field data 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, confirming no systemic issue for the lot.A review of labeling was performed and found to sufficiently address the customer's issue.Based on the investigation, no systemic issue or deficiency was identified with the architect prolactin reagent, lot number 74400ud00.
Event or Problem Description
The customer reported falsely elevated architect prolactin results generated by the alinity i processing module for two female patients.These results were inconsistent with the results produced by other platforms.The following data were provided: customer¿s normal range for women: 5.18 to 26.53 ng/ml patient 1 (42-year-old): sample id: (b)(6) first blood draw: architect prolactin result = 27 ng/ml roche platform result = 13 ng/ml and 13 ng/ml.On (b)(6) 2025 (second blood draw): architect prolactin result = 22.91 ng/ml chemiluminescence method = 13 ng/ml.Patient¿s historical result = 44 ng/ml.Patient 2 (47-year-old): sample id: (b)(6) 26nov2025 (first blood draw): architect prolactin result = 47.39 ng/ml roche platform result = 16 ng/ml.On (b)(6) 2025 (second blood draw): architect prolactin result = 48.42 ng/ml chemiluminescence method = 13 ng/ml maglumi platform result = 15 ng/ml.Patient¿s historical result = 44 ng/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: 24367656
• Report Number: 3005094123-2026-00078
• Device Sequence Number: 20162416
• Product Code: CFT
• UDI-Device Identifier: 00380740014865
• UDI-Public: (01)00380740014865(17)260326(10)74400UD00
• Combination Product (Y/N): N
• Initial Reporter Country: AR
• 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): 03/24/2026

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: 01/28/2026
• Supplement Date Received by Manufacturer: 03/24/2026
• Initial Report FDA Received Date: 02/17/2026
• Supplement Report FDA Received Date: 03/24/2026
• 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 I1000SR MOD, 01L86-01, (B)(6); ARC I1000SR MOD, 01L86-01, (B)(6)
• Patient Sex: Unknown