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	02/09/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The customer observed falsely positive alinity i prolactin for one sample when compared to other methods.(abbott reference 3.46 to 19.40 ng/ml).(b)(6) 2024 sid (b)(6) alinity initial result 58.58 ng/ml, repeat result 56.31 ng/ml.Siemens results 11.10 ng/ml (siemens reference range 2.10 to 17.70 ng/ml).Beckman result 19.95 ng/ml (beckman reference range 2.10 to 17.10 ng/ml).No impact to patient management was reported.
Additional Manufacturer Narrative
An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.Section a1 patient identifier complete information: (b)(6).Section e1 phone number complete information: (b)(6).All available patient information was included.Additional patient details are not available.
Event or Problem Description
The customer observed falsely positive alinity i prolactin for one sample when compared to other methods.(abbott reference 3.46 to 19.40 ng/ml).(b)(6) 2024 sid (b)(6) alinity initial result 58.58 ng/ml, repeat result 56.31 ng/ml.Siemens results 11.10 ng/ml (siemens reference range 2.10 to 17.70 ng/ml).Beckman result 19.95 ng/ml (beckman reference range 2.10 to 17.10 ng/ml).No impact to patient management was reported.
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 in house testing.Return testing was not completed as returns were not available.Review of all the information provided by the customer was reviewed.A ticket search by lot indicates that the reagent lot performs as expected.Trending review did not identify any trends for the issue for the product.The device history record review did not identify any non-conformances or deviations relating to the complaint under review.Labeling was reviewed and sufficiently addresses the customer's issue.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.Based on the investigation, no systemic issue or deficiency with the alinity i prolactin assay for lot 53596ud00 was identified.All available patient information was included.Additional patient details are not available.

• 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: 19059579
• Report Number: 3005094123-2024-00173
• Device Sequence Number: 20521206
• Product Code: CFT
• UDI-Device Identifier: 00380740121587
• UDI-Public: (01)00380740121587(17)240615(10)53596UD00
• 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): 06/14/2024

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: 06/15/2024
• Device Catalogue Number: 07P66-30
• Device Lot Number: 53596UD00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/26/2024
• Supplement Date Received by Manufacturer: 06/14/2024
• Initial Report FDA Received Date: 04/08/2024
• Supplement Report FDA Received Date: 06/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/13/2023
• 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