| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2024-RN-00148-1 |
| Product Name/Description |
myMerlinPulse Patient Application
Model number: APP1004 (Android) and APP1005 (iOS)
ARTG's 338156, 338155 |
| Recall Action Level |
Consumer |
| Recall Action Classification |
Class III |
| Recall Action Commencement Date |
3/04/2024 |
| Responsible Entity |
|
| Reason/Issue |
The myMerlinPulse Patient Application (iOS App1005 and Android App 1004) may not connect using Bluetooth to Gallant family devices after being paired for 2 years. To re-enable Bluetooth connection, the patient needed to attend a clinic and the device interrogated with the Merlin Programmer.
The issue occurs because the Patient App Identity Record, which is created by Merlin.net for each myMerlinPulse app during the process of pairing to the device, is incorrectly set to expire in 2 years. The intended expiration is 10 years.
This action was undertaken prior to TGA notification. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
All customers have received the updated software described below.
This problem was successfully addressed by re-pairing to the Patient App when prompted by a phone push notification sent by Abbott prior to the 2-year expiration period. Patients could re-pair on their own with troubleshooting material publicly available online or by calling Technical Support.
Additionally, Merlin.net was updated to match the expected validity period of 10 years on August 1, 2022, a new version of iOS App1005 v1.0.107 was released starting October 2023, and a new version Android App1004 v1.0.106 was released starting October 2022 to ensure the appropriate 10-year expiration period.
This action has been closed out on 29/05/2024 |
| Contact Information |
02 8879 2877 - John Kilbridge, Abbott Medical Australia |