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	10/30/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
All available patient information was included.Additional patient details are not available.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.This report is for lot 53599ud00 & mfr number 3005094123-2023-00312 was submitted for lot number 52220ud00.
Event or Problem Description
The customer reported falsely elevated alinity i prolactin and provided the following example data: female patient data: customer normal values are: 5.18 - 28 ng/ml.Patient 1 initial result was 28.95 ng/ml and retest result was 19.7 ng/ml.Patient 2 initial result was 65.15 ng/ml and retest result was 28.3 ng/ml.Patient 3 initial result was 26.72 ng/ml and retest result was 19.1 ng/ml.Male data provided: customer normal values are: 3.46 - 19.40 ng/ml.The customer tested 3 male samples that were from reportedly healthy individuals and obtained the following results: 23.9, 9.67, & 19.62.No other info available for these patients.The customer reported lot 52220ud00 and lot 53599ud00 were on-board the analyzer when the discrepant results were obtained.There was no reported impact to patient management.
Event or Problem Description
The customer reported falsely elevated alinity i prolactin and provided the following example data: female patient data: customer normal values are: 5.18 - 28 ng/ml.Patient 1 initial result was 28.95 ng/ml and retest result was 19.7 ng/ml.Patient 2 initial result was 65.15 ng/ml and retest result was 28.3 ng/ml.Patient 3 initial result was 26.72 ng/ml and retest result was 19.1 ng/ml.Male data provided: customer normal values are: 3.46 - 19.40 ng/ml.The customer tested 3 male samples that were from reportedly healthy individuals and obtained the following results: 23.9, 9.67, & 19.62.No other info available for these patients.The customer reported lot 52220ud00 and lot 53599ud00 were on-board the analyzer when the discrepant results were obtained.There was no reported impact to patient management.
Additional Manufacturer Narrative
The complaint investigation 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 completed as specimen sample was returned for testing.Data and information provided by the customer were reviewed and support the complaint issue without indication for any additional issue.Device history review did not identify any potential nonconformances, nonconformances, or deviations associated with the complaint lot and customer reported issue.Ticket search by lot identified lot 53599ud00 did not have an increase in complaint activity, however the review of ticket and trending did not identify any trends.In house testing was performed on lot 53599ud00, which concluded testing met acceptance criteria indicating the product is performing as expected.Labeling was reviewed and was found to address the customer reported issue.Based on the available information, no systemic issue or deficiency was identified for the alinity i prolactin lot 53599ud00.

• 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: 18120856
• Report Number: 3005094123-2023-00313
• Device Sequence Number: 18018297
• Product Code: CFT
• UDI-Device Identifier: 00380740121570
• UDI-Public: 00380740121570
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: N/A
• 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): 02/19/2024

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: 07P66-20
• Device Lot Number: 53599UD00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/30/2023
• Supplement Date Received by Manufacturer: 02/08/2024
• Initial Report FDA Received Date: 11/13/2023
• Supplement Report FDA Received Date: 02/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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