MAUDE Adverse Event Report: A.I.D.D LONGFORD ARCHITECT PROLACTIN

Catalog Number 07K76-25

Device Problem Low Test Results (2458)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/01/2018

Event Type  malfunction  

Manufacturer Narrative

An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.Patient information, no further patient information was provided.

Event Description

The customer reported a falsely depressed architect prolactin result for a patient with a large pituitary tumor (prolactinoma).Sample id (b)(4) generated a result of 106.5 miu/l which the customer believed was lower than expected based on the patient's clinical picture.The customer further tested the sample with multiple dilutions including 1:10 autodilution and manual dilutions with multi-assay diluent as recommended by the package insert.All dilutions generated results below the reportable limit.The sample was further evaluated with multiple dilutions using a serum sample with a low prolactin (22.6 miu/l).The results ranged from 125.8 miu/l with a 1:2 dilution to 28701.6 miu/l with a 1:1200 dilution.No adverse impact to patient management was reported.

Manufacturer Narrative

Review of complaint activity did not identify any adverse or non-statistical trends for the architect prolactin assay.An increase in complaint activity was not identified for reagent lot 84028ui00.Testing was performed using an in-house retain kit of lot 84028ui00.All specifications were met indicating the lot is preforming acceptably.Manufacturing documentation for the likely cause lot did not identify any issues associated with the complaint issue.Additionally, labeling was reviewed and sufficiently addresses the customer's issue.Based on the available information, no systemic issue or deficiency of the architect prolactin assay was identified.

• Brand Name: ARCHITECT PROLACTIN
• Type of Device: PROLACTIN
• Manufacturer (Section D): A.I.D.D LONGFORD; lisnamuck; co. longford; longford NA ; EI NA
• MDR Report Key: 7702977
• MDR Text Key: 114810301
• Report Number: 3005094123-2018-00024
• Device Sequence Number: 1
• Product Code: CFT
• UDI-Device Identifier: 00380740014865
• UDI-Public: 00380740014865
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 08/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2018
• Device Catalogue Number: 07K76-25
• Device Lot Number: 84028UI00
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 08/22/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARCHITECT I2000SR ANALYZER,; ARCHITECT I2000SR ANALYZER,; LIST 03M74, SERIAL (B)(4) ; LIST 03M74, SERIAL (B)(4)