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	02/01/2023
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.
Event or Problem Description
The customer observed falsely elevated architect prolactin result for three samples.The following data was provided (3-29 ng/ml-normal range): patient 1 sid (b)(6) (female) prolactin initial 32.84 ng/ml, repeated in another lab (chemiluminescence) 13.0 ng/ml (patient 2 sid (b)(6) (male) prolactin initial 47.73 ng/ml, repeated in another lab (chemiluminescence) 11.2 ng/ml patient 3 sid (b)(6) (woman) prolactin initial 62.8 ng/ml, repeated in another lab (chemiluminescence) 39.3 ng/ml.No impact to patient management was reported.
Additional Manufacturer Narrative
Data and information provided were reviewed and support the complaint issue without indication for any additional issue.Return testing was not performed as returns were not available.Device history record review was performed on lot 39373ud00, which did not show any potential non-conformances, deviations, or non-conformances.Trending review did not identify any trends.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 review concludes that the issue is adequately addressed.Based on the investigation, no systemic issue or deficiency of the architect prolactin assay was identified.

• 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: 16427898
• Report Number: 3005094123-2023-00050
• Device Sequence Number: 2645421
• 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): 03/14/2023

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: 04/15/2023
• Device Model Number: 7K76-25
• Device Catalogue Number: 07K76-25
• Device Lot Number: 39373UD00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/01/2023
• Supplement Date Received by Manufacturer: 03/08/2023
• Initial Report FDA Received Date: 02/23/2023
• Supplement Report FDA Received Date: 03/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/22/2022
• 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 I2000SR REFURB-MEXI, 03M74-84, ISR52282; ARC I2000SR REFURB-MEXI, 03M74-84, ISR52282
• Patient Sex: Unknown