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	11/23/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Section a1 patient identifier complete information: (b)(6), 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.
Event or Problem Description
The customer observed falsely elevated alinity i prolactin results for one sample.Sid (b)(6), initial result = 108.04 ng/ml (lot 65355ud00), repeat result at a reference lab = 38.87 ng/ml, same sample was tested on another lot with result of = 107.37 ng/ml (lot 67389ud00).No impact to patient management was reported.
Additional Manufacturer Narrative
Additional information in section a3a - sex, b3 - date of event, b5 - describe event or problem, h10 - related report numbers.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 in house testing.Return testing was not completed 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.Review of tracking and trending for the alinity i 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 65355ud00.The device history record review did not identify any non-conformances or deviations relating to the complaint under review.In house accuracy testing was completed using panels which mimic patient samples using an in-house retained kit stored at the recommended storage condition.All specifications were met indicating that the lot is performing acceptably.Labeling was reviewed and sufficiently addresses the customer's issue.Based on the investigation, no systemic issue or deficiency with the alinity i prolactin assay for lot 65355ud00 was identified.All available patient information was included.Additional patient details are not available.
Event or Problem Description
The customer observed falsely elevated alinity i prolactin results for one sample.Sid (b)(6) initial result = 108.04 ng/ml (lot 65355ud00), repeat result at a reference lab = 38.87 ng/ml, same sample was tested on another lot with result of = 107.37 ng/ml (lot 67389ud00) no impact to patient management was reported.Additional information provided on 10feb2025.The patient is female and the initial result of 108.04 ng/ml was performed on (b)(6) 2024 and the repeat result of 107.37 ng/ml was performed on (b)(6) 2024.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: 20939325
• Report Number: 3005094123-2024-00643
• Device Sequence Number: 4514492
• Product Code: CFT
• UDI-Device Identifier: 00380740121587
• UDI-Public: (01)00380740121587(17)250626(10)65355UD00
• Combination Product (Y/N): N
• Initial Reporter Country: PK
• 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): 02/19/2025

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: 06/26/2025
• Device Catalogue Number: 07P66-30
• Device Lot Number: 65355UD00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/27/2024
• Supplement Date Received by Manufacturer: 02/18/2025
• Initial Report FDA Received Date: 12/16/2024
• Supplement Report FDA Received Date: 02/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/11/2024
• 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: ALNTY I PROCESSING MODU, 03R65-01, AI01917; ALNTY I PROCESSING MODU, 03R65-01, AI01917
• Patient Sex: Female