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	09/04/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Section a patient information: refer to section b5 for complete patient information an evaluation is in process.A follow-up report will be submitted when the evaluation is complete.Additional information for section h10 related report numbers: 3005094123-2026-00113.
Event or Problem Description
The customer reported falsely elevated alinity i prolactin results for a 62-year-old male patient.The following data was provided: (b)(6) 2025, sid (b)(6): initial result (lot 72165ud00, (b)(6) = 1980.092 ng/ml, repeat with 1:10 dilution (b)(6) = 3083.830 ng/ml, repeat with no dilution (b)(6) = 3230.905 ng/ml.(b)(6) 2025, sid (b)(6): initial result (lot 75050ud00, (b)(6) = 2225.910 ng/ml, repeat (b)(6) = 3468.409 ng/ml, repeat with 1:10 dilution (b)(6) = 3229.661 ng/ml.(b)(6) 2026, sid (b)(6): initial result = 3092.7 ng/ml.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: 24547899
• Report Number: 3005094123-2026-00111
• Device Sequence Number: 12184620
• Product Code: CFT
• UDI-Device Identifier: 00380740121570
• UDI-Public: (01)00380740121570(17)260326(10)75050UD00
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 05/05/2026

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: 03/26/2026
• Device Catalogue Number: 07P66-20
• Device Lot Number: 75050UD00
• 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: 02/16/2026
• Supplement Date Received by Manufacturer: 04/23/2026
• Initial Report FDA Received Date: 03/09/2026
• Supplement Report FDA Received Date: 05/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/08/2025
• 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); ALNTY I PROLACTIN 200T, 07P66-20, 72165UD00; ALNTY I PROLACTIN 200T, 07P66-20, 77504UD00
• Patient Age: 62 YR
• Patient Sex: Male