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

Model Number 7K76-35

Device Problem Low Test Results (2458)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/24/2022

Event Type  malfunction  

Event Description

The customer observed falsely depressed architect prolactin results for one sample that was questioned by the physician.The patient sample persistently generated architect prolactin results below 350 miu/l.However, prolactin result from another clinic is recovering 600 to 1000 miu/l (unknown method).The physician is inquiring about potential negative interference with the architect prolactin assay.No impact to patient management was reported.

Manufacturer Narrative

An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Manufacturer Narrative

The complaint investigation for falsely depressed architect prolactin results 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 field data review.Return testing was not completed as returns were not available.Trending review did not identify any trends for the issue for the product.Device history record review did not identify any non-conformances or deviations with list number 07k76-35 and the complaint issue.The overall performance of architect prolactin was reviewed using field data from customers worldwide.The lot number is unknown in this case, however review of the within date lots show that all median values are within ±2sd of the mean indicating that the lots are comparable and performing acceptably in the field.Labeling was reviewed and found to be adequate.Based on our investigation, no systemic issue or deficiency with the architect prolactin reagent for unknown lot number was identified.

• Brand Name: ARCHITECT PROLACTIN REAGENT KIT
• Type of Device: 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: 14462724
• MDR Text Key: 296165906
• Report Number: 3005094123-2022-00104
• Device Sequence Number: 1
• Product Code: CFT
• UDI-Device Identifier: 00380740105990
• UDI-Public: 00380740105990
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 7K76-35
• Device Catalogue Number: 07K76-35
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/29/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARC I2000SR INST, 03M74-02, (B)(6) ; ARC I2000SR INST, 03M74-02, (B)(6)