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	09/29/2025
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.A1 - patient identifier: complete sample id (b)(6).All available patient information was included.Additional patient details are not available.
Event or Problem Description
The customer reported a falsely elevated architect prolactin result generated on the architect i1000sr for one female patient.The following data was provided: (b)(6) 2025, sample id (b)(6): initial result = 20.79 ng/ml (abbott normal value: 3.46-19.40 ng/ml).Sample tested at another lab (another technique): result = 8 ng/ml (normal range: 5-16 ng/ml).There was no impact to patient management reported.
Additional Manufacturer Narrative
An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.A1: patient identifier: (b)(6) (total of 2 patients).All available patient information was included.Additional patient details are not available.
Event or Problem Description
On 01dec2025, additional patient results were provided by the customer for falsely elevated architect prolactin results.The customer sent two patients to be rerun at cerba.The following results were provided: on (b)(6) 2025, sid: (b)(6): architect prolactin result: 31.93 ng/ml (reference range: 3.46-19.40 ng/ml).Cerba prolactin result: 17 ng/ml (normal range: < 20 ng/ml).On (b)(6) 2025, sid: (b)(6): architect prolactin result: 23.64 ng/ml (reference range: 3.46-19.40 ng/ml).Cerba prolactin result: 14 ng/ml (normal range: < 20 ng/ml).There was no impact to patient management reported.
Additional Manufacturer Narrative
Data and information provided by the customer were reviewed and support the complaint issue.The ticket search by lot did not identify an increase in complaint activity for the complaint issue.Tracking and trending for the architect prolactin reagent did not identify any related trends.Device history review did not identify any nonconformances, potential nonconformance or deviations associated with the complaint lot number.Device history record review did not identify any nonconformances, potential nonconformances or deviations associated with lot number 76355ud00 and complaint issue.In-house accuracy testing was completed using panels which mimic patient samples using an in-house retained kit of lot 76355ud00.All specifications were met indicating that the lot is performing acceptably.Based on the investigation, no systemic issue or deficiency of the architect prolactin, lot 76355ud00 was identified.
Event or Problem Description
The customer reported a falsely elevated architect prolactin result generated on the architect i1000sr for one female patient.The following data was provided: (b)(6) 2025, sample id (b)(6): initial result = 20.79 ng/ml (abbott normal value: 3.46-19.40 ng/ml) sample tested at another lab (another technique): result = 8 ng/ml (normal range: 5-16 ng/ml) on (b)(6) 2025, additional patient results were provided by the customer for falsely elevated architect prolactin results.The customer sent two patients to be rerun at cerba.The following results were provided: on (b)(6) 2025, sid (b)(6): architect prolactin result: 31.93 ng/ml (reference range: 3.46-19.40 ng/ml) cerba prolactin result: 17 ng/ml (normal range: < 20 ng/ml).On (b)(6) 2025, sid (b)(6): architect prolactin result: 23.64 ng/ml (reference range: 3.46-19.40 ng/ml) cerba prolactin result: 14 ng/ml (normal range: < 20 ng/ml).There was no impact to patient management 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: 23335547
• Report Number: 3005094123-2025-00519
• Device Sequence Number: 15930119
• Product Code: CFT
• UDI-Device Identifier: 00380740014865
• UDI-Public: (01)00380740014865(17)260519(10)76355UD00
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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,Followup
• Report Date (Section B): 02/05/2026

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: 05/19/2026
• Device Catalogue Number: 07K76-25
• Device Lot Number: 76355UD00
• 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: 10/14/2025
• Supplement Date Received by Manufacturer: 12/01/2025; 02/03/2026
• Initial Report FDA Received Date: 10/20/2025
• Supplement Report FDA Received Date: 12/22/2025; 02/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/06/2025
• 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 INTGR, 01L86-40, (B)(6).; ARC I1000SR INTGR, 01L86-40, (B)(6).; ARC I1000SR INTGR, 01L86-40, (B)(6).
• Patient Sex: Female