MAUDE Adverse Event Report: ABBOTT IRELAND DIAGNOSTICS DIVISION ALINITY I PROLACTIN REAGENT KIT; RADIOIMMUNOASSAY, PROLACTIN (LACTOGEN)

Catalog Number	07P66-30
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/25/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported falsely elevated alinity i prolactin results when compared to siemens, beckman, and atellica.The following example data was provided: (b)(6) 2025, sid (b)(6) (36 year old male): initial result = 49.16 ng/ml, siemens result = 25.12 ng/ml, additional data was provided by the customer for samples that were screened for macroprolactin with peg: sid (b)(6) (50 year old male): atellica result = 68.10, alinity result = 95.36, peg atellica = 66.88, peg alinity = 95.56.Sid (b)(6) (45 year old male): atellica result = 29.24, alinity result = 182.53, peg atellica = 14.50, peg alinity = 32.74.Sid (b)(6) (50 year old female): atellica result = 28.94, alinity result = 160.89, peg atellica = 16.5, peg alinity = 37.42.Sid (b)(6) (36 year old male): atellica result = 25.12, alinity result = 49.16, peg atellica = 13.78, peg alinity = 19.6.Sid (b)(6) (17 year old female): atellica result = 21.97, alinity result = 32.87, peg atellica =21.68, peg alinity = 27.54.Sid (b)(6) (51 year old female): atellica result = 16.25, alinity result = 30.35, peg atellica = 12.1 , peg alinity = 15.26.Sid (b)(6) (43 year old female): atellica result = 52.22, alinity result = 88.82, peg atellica = 32.42, peg alinity = 43.74 no impact to patient management was reported.
Additional Manufacturer Narrative
Complete entry for section a patient information: sid (b)(6) (50 year old male).Sid (b)(6) (45 year old male).Sid (b)(6) (50 year old female).Sid (b)(6) (36 year old male).Sid (b)(6) (17 year old female).Sid (b)(6) (51 year old female).Sid (b)(6) (43 year old female).An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.All available patient information was included.Additional patient details are not available.
Additional Manufacturer Narrative
The complaint investigation for false elevated alinity i prolactin results 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 field data review.Data and information provided by the customer were reviewed and support the complaint issue.A review of tracking and trending did identify a slight increase in complaints for list number 07p66, however, an increase in complaint activity for lot number 76187ud00 was not identified.A device history record review did not identify issues associated with the customer¿s observation.The overall performance of alinity i prolactin reagents in the field was reviewed using data from customers worldwide.The review shows that the median patient result for the master lot falls within +/-2sd of the established baseline, indicating the reagent lot is performing acceptably.Labeling was reviewed which adequately addresses the current issue.Based on the investigation, no systemic issue or deficiency of the alinity i prolactin reagent lot 76187ud00 was identified.All available patient information was included.Additional patient details are not available.
Event or Problem Description
The customer reported falsely elevated alinity i prolactin results when compared to siemens, beckman, and atellica.The following example data was provided: (b)(6) 2025, sid (b)(6) (36 year old male): initial result = 49.16 ng/ml, siemens result = 25.12 ng/ml, additional data was provided by the customer for samples that were screened for macroprolactin with peg: sid (b)(6) (50 year old male): atellica result = 68.10, alinity result = 95.36, peg atellica = 66.88, peg alinity = 95.56, sid (b)(6) (45 year old male): atellica result = 29.24, alinity result = 182.53, peg atellica = 14.50, peg alinity = 32.74, sid (b)(6) (50 year old female): atellica result = 28.94, alinity result = 160.89, peg atellica = 16.5, peg alinity = 37.42, sid (b)(6) (36 year old male): atellica result = 25.12, alinity result = 49.16, peg atellica = 13.78, peg alinity = 19.6, sid (b)(6) (17 year old female): atellica result = 21.97, alinity result = 32.87, peg atellica =21.68, peg alinity = 27.54, sid (b)(6) (51 year old female): atellica result = 16.25, alinity result = 30.35, peg atellica = 12.1, peg alinity = 15.26, sid (b)(6) (43 year old female): atellica result = 52.22, alinity result = 88.82, peg atellica = 32.42, peg alinity = 43.74 no impact to patient management was reported.

• 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: 24080819
• Report Number: 3005094123-2026-00024
• Device Sequence Number: 5879006
• Product Code: CFT
• UDI-Device Identifier: 00380740121587
• UDI-Public: (01)00380740121587(17)260507(10)76187UD00
• 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): 03/12/2026

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: 05/07/2026
• Device Catalogue Number: 07P66-30
• Device Lot Number: 76187UD00
• 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: 01/02/2026
• Supplement Date Received by Manufacturer: 03/06/2026
• Initial Report FDA Received Date: 01/15/2026
• Supplement Report FDA Received Date: 03/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/26/2025
• 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).
• Patient Sex: Unknown