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

Catalog Number	07P66-20
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/10/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer observed falsely elevated alinity i prolactin results for 9-year-old female patient who is not pregnant.The sample was repeated using the siemens method with lower results.The following data was provided: sid: (b)(6) alinity result = 110 ng/ml.Sent to another lab alinity result for sid 10276218 = 110 ng/ml.Siemens result = 24 ng/ml.No impact to patient management was reported.
Additional Manufacturer Narrative
Complete information from section a1 patient identifier sid: (b)(6).This report is being filed on an international product, list number: 07p66-20 that has a similar product distributed in the us, list number: 07p66, with 510k exempt.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.All available patient information has been included.No additional patient details are available.Cross reference emdr for ticket (b)(4).
Event or Problem Description
The customer observed falsely elevated alinity i prolactin results for 9 year old female patient who is not pregnant.The sample was repeated using the siemens method with lower results.The following data was provided: sid (b)(6) alinity result = 110 ng/ml.Sent to another lab alinity result for sid (b)(6) = 110 ng/ml.Siemens result = 24 ng/ml.No impact to patient management was reported.
Additional Manufacturer Narrative
Data and information provided by the customer were reviewed and support the complaint issue.Review of tracking and trending data identified an increase in complaints for the alinity i prolactin assay as well as an increase in complaint activity for the complaint lot.However, testing was performed utilizing retained kits of the complaint lot and noted that all testing passed, indicating the reagent lots are performing as expected.Device history record review did not identify any non-conformances or deviations associated with lot 72165ud00 and the complaint issue.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 72165ud00 was identified.

• 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: 23133535
• Report Number: 3005094123-2025-00471
• Device Sequence Number: 9285306
• Product Code: CFT
• UDI-Device Identifier: 00380740121570
• UDI-Public: (01)00380740121570(17)260108(10)72165UD00
• Combination Product (Y/N): N
• Initial Reporter Country: GR
• 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): 12/17/2025

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: 01/08/2026
• Device Catalogue Number: 07P66-20
• Device Lot Number: 72165UD00
• 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: 09/15/2025
• Supplement Date Received by Manufacturer: 12/12/2025
• Initial Report FDA Received Date: 09/24/2025
• Supplement Report FDA Received Date: 12/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/29/2025
• 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 Age: 9 YR
• Patient Sex: Female