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	05/14/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complete entry for section a1 - patient identifier: (b)(6).An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.Section a patient information: refer to section b5 for complete patient information.
Event or Problem Description
The customer observed a falsely elevated alinity i prolactin for a 52-year-old female.The following results were provided (reference range 108.8 to 557.1 miu/l): (b)(6) 2026, sid (b)(6), initial prolactin result (lot 84437ud00, analyzer (b)(6)= 1398.20 miu/l; repeat result= 1,379.36 miu/l; (b)(6) 2026, sid (b)(6), prolactin result (lot 85609ud00, analyzer (b)(6)= 1,225.33 miu/l; repeat using beckman platform= 298 miu/l (reference range 83 to 504 miu/l); repeat using roche platform= 492 miu/l (reference range 102 to 496 miu/l) there was no impact to patient management 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 ; +49()6122582960
• MDR Report Key: 25256099
• Report Number: 3005094123-2026-00244
• Device Sequence Number: 17497259
• Product Code: CFT
• UDI-Device Identifier: 00380740121570
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/10/2026

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 Catalogue Number: 07P66-20
• Device Lot Number: 85609UD00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/18/2026
• Supplement Date Received by Manufacturer: 09/10/2026
• Initial Report FDA Received Date: 05/22/2026
• Supplement Report FDA Received Date: 09/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/24/2026
• 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
• Usage of Device: N
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ALNTY I PROCESSING MODU, 03R65-01, (B)(6)
• Patient Age: 52 YR
• Patient Sex: Female