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	05/13/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported falsely elevated architect prolactin results generated on the architect i2000sr analyzer for multiple patients.The initial results were not released out of the lab.The issue was not resolved after recalibrating the reagent, and the prolactin results were still elevated.The prolactin reagent was calibrated on a second analyzer which generated similar results.The customer sent the samples to a support laboratory, those same samples generated lower results.The following data was provided: sid (b)(6): pro-sangue results = 27.38 / 27.45 ng/ml; support lab 1 result = 20.04 ng/ml.Sid (b)(6): pro-sangue results = 67.20 / 74.31 / 71.39 ng/ml; support lab 1 result = 17.29 ng/ml; support lab 2 result = 14.6 ng/ml.Sid (b)(6): pro-sangue result = 41.5 ng/ml; support lab 2 result = 28.1 ng/ml.The customer¿s (pro-sangue) reference range for prolactin is 1.9 to 27.00 ng/ml.The support lab reference range for prolactin is 2.80 to 29.20 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) (3 total patients) all available patient information was included.Additional patient details are not available.
Event or Problem Description
The customer reported falsely elevated architect prolactin results generated on the architect i2000sr analyzer for multiple patients.The initial results were not released out of the lab.The issue was not resolved after recalibrating the reagent, and the prolactin results were still elevated.The prolactin reagent was calibrated on a second analyzer which generated similar results.The customer sent the samples to a support laboratory, those same samples generated lower results.The following data was provided: sid (b)(6): pro-sangue results = 27.38 / 27.45 ng/ml; support lab 1 result = 20.04 ng/ml.Sid (b)(6): pro-sangue results = 67.20 / 74.31 / 71.39 ng/ml; support lab 1 result = 17.29 ng/ml; support lab 2 result = 14.6 ng/ml.Sid (b)(6): pro-sangue result = 41.5 ng/ml; support lab 2 result = 28.1 ng/ml.The customer¿s (pro-sangue) reference range for prolactin is 1.9 to 27.00 ng/ml.The support lab reference range for prolactin is 2.80 to 29.20 ng/ml.There was no impact to patient management reported.
Additional Manufacturer Narrative
The complaint investigation included a review of data and information provided by the customer, search for similar complaints, ticket trending review, labeling review, device history record review, and in-house testing was performed on a retained kit of the complaint lot.Return testing was not performed as returns were not available.Data and information provided by the customer were reviewed and support the complaint issue without indication for any additional issue.A review of tracking and trending for the architect prolactin assay did not identify an increase in complaint activity related to the complaint issue.Additionally, an increase in complaint activity was not identified for reagent lot 70290ud00.A review of the device history record did not identify any nonconformances or deviations associated with the complaint lot and complaint issue.Accuracy testing was completed using panels which mimic patient samples using an in-house retained kit of lot number 70290ud00 stored at the recommended storage condition.All specifications were met indicating that the lot is performing acceptably.Labeling was reviewed and adequately addresses the current issue.Based on the investigation, no systemic issue or product deficiency of the architect prolactin reagent lot 70290ud00 was identified.Section d3 suspect medical device was updated including the email section g1 all manufacturers was updated including the mfg site email.

• 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: 22097437
• Report Number: 3005094123-2025-00261
• Device Sequence Number: 15309710
• Product Code: CFT
• UDI-Device Identifier: 00380740014865
• UDI-Public: (01)00380740014865(17)251025(10)70290UD00
• 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): 08/26/2025

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: 10/25/2025
• Device Catalogue Number: 07K76-25
• Device Lot Number: 70290UD00
• 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: 05/13/2025
• Supplement Date Received by Manufacturer: 08/18/2025
• Initial Report FDA Received Date: 05/28/2025
• Supplement Report FDA Received Date: 08/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/26/2024
• 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),; ARC I2000SR INST, 03M74-02, (B)(6),; ARC I2000SR INST, 03M74-02, (B)(6).
• Patient Sex: Unknown