MAUDE Adverse Event Report: A.I.D.D LONGFORD ARCHITECT PROLACTIN REAGENT KIT; RADIOIMMUNOASSAY, PROLACTIN (LACTOGEN)

Model Number	7K76-25
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/29/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
All available patient information is included.Additional patient details are not available.Postal code: a leading zero was added to the field because the system requires a minimum of 5 digits in the postal code field an evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Event or Problem Description
The customer observed a falsely elevated architect prolactin result for a patient sample.Sid (b)(6).Initial result: 53.07 ng/ml, repeat result: 52.95 ng/ml (reference range female: 5.18-26.53 ng/ml) the laboratory does not carry out the peg method to exclude interference with macroprolactin.The customer sent the sample out to another laboratory that uses the centaur cmia technique and obtained a result of 19.9 ng/ml (reference range: 2.7-29.0 ng/ml) there was no impact to patient management reported.
Additional Manufacturer Narrative
The complaint investigation for falsely elevated architect prolactin results included a search for similar complaints, and the review of complaint text, trending data, labeling, and device history records.Return testing was not performed as returns were not available.The ticket search by lot indicates that the reagent lot performs as expected for the product.A review of tracking and trending did not identify any related trends.Accuracy testing was completed using panels which mimic patient samples using an in-house retained kit of the complaint lot stored at the recommended storage condition.All specifications were met indicating that the lot is performing acceptably.The device history records were reviewed and did not identify any non-conformances or deviations related to the complaint under review.Labeling was reviewed and adequately addresses the issue under review.Based on the investigation, no systemic issue or product deficiency for architect prolactin reagent lot 34434ud00 was identified.This follow up includes a correction to include the codes in section h6 for component code, type of investigation, investigation findings and investigation conclusions that were not included in the initial report.

• Brand Name: ARCHITECT PROLACTIN REAGENT KIT
• Common Device Name: RADIOIMMUNOASSAY, PROLACTIN (LACTOGEN)
• Manufacturer (Section D): A.I.D.D LONGFORD; lisnamuck; co. longford; longford N39E9 32; EI N39E932
• Manufacturer (Section G): A.I.D.D LONGFORD; lisnamuck; co. longford; longford N39E9 32; EI N39E932
• Manufacturer Contact: siobhan wright ; lisnamuck; post market surveillance; longford N39 E-932 ; EI N39 E932 ; 433331157
• MDR Report Key: 15226051
• Report Number: 3005094123-2022-00172
• Device Sequence Number: 14844453
• Product Code: CFT
• UDI-Device Identifier: 00380740014865
• UDI-Public: 00380740014865
• Combination Product (Y/N): N
• Initial Reporter Country: AR
• 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): 09/26/2022

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: 12/06/2022
• Device Model Number: 7K76-25
• Device Catalogue Number: 07K76-25
• Device Lot Number: 34434UD00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/29/2022
• Supplement Date Received by Manufacturer: 09/06/2022
• Initial Report FDA Received Date: 08/15/2022
• Supplement Report FDA Received Date: 09/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/14/2021
• 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: ARC I1000SR INTGR, 01L86-40, I1SR61227.; ARC I1000SR INTGR, 01L86-40, I1SR61227.
• Patient Sex: Unknown