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	09/25/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An evaluation is in process.A follow up report will be submitted when the evaluation is complete.Section a1 patient identifier sids: (b)(6).See mr# 3005094123-2023-00305 for the other lot number.
Event or Problem Description
The customer reported falsely elevated alinity i prolactin results on a patient.The following results were provided: (b)(6) 2023 sid (b)(6) = 108.08 ng/ml, another alinity = 112.81 ng/ml.(b)(6) 2023 sample tested at another laboratory = 17.6 ng/ml (methodology unknown).New sample: (b)(6) 2023 sid (b)(6) = 80.71 ng/ml.No impact to patient management was reported.
Event or Problem Description
The customer reported falsely elevated alinity i prolactin results on a patient.The following results were provided: (b)(6) 2023 sid (b)(6)= 108.08 ng/ml, another alinity = 112.81 ng/ml (b)(6) 2023 sample tested at another laboratory = 17.6 ng/ml (methodology unknown) new sample: (b)(6) 2023 sid(b)(6) = 80.71 ng/ml.No impact to patient management was reported.
Additional Manufacturer Narrative
A review of complaints for the alinity i prolactin (list 7p66), lot# 48477ud00 and 52217ud00 assays determined that there are no trends for the product related to patient results.Return testing was not completed as returns were not available.A retained kit of reagent lots 48477ud00 and 52217ud00 were tested for accuracy and the data shows that the performance of the lots are performing acceptably.A review of the manufacturing documentation did not identify any issues associated with the customer¿s observation.A review of the product labeling concluded that the issue is sufficiently addressed.Based on the investigation no systemic issue or product deficiency was identified for the alinity i prolactin (list 7p66), lot# 48477ud00 and 52217ud00.See mr# 3005094123-2023-00305 for the other lot number.

• 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: 18077824
• Report Number: 3005094123-2023-00306
• Device Sequence Number: 6788587
• Product Code: CFT
• UDI-Device Identifier: 00380740121587
• UDI-Public: 00380740121587
• 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): 01/24/2024

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: 05/10/2024
• Device Catalogue Number: 07P66-30
• Device Lot Number: 52217UD00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/18/2023
• Supplement Date Received by Manufacturer: 01/23/2024
• Initial Report FDA Received Date: 11/06/2023
• Supplement Report FDA Received Date: 01/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/14/2023
• 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, 03R65-01, (B)(6).; ALNTY I, 03R65-01, (B)(6).
• Patient Sex: Unknown