MAUDE Adverse Event Report: ABBOTT GALLANT DR; NO MATCH

Model Number CDDRA500Q

Device Problem Failure to Interrogate (1332)

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

Event Date 12/15/2023

Event Type  malfunction  

Event Description

It was reported, the device became disconnected from remote monitoring via bluetooth (ble).The patient presented in clinic and the device was also unable to be interrogated using ble.Technical support was contacted and recommended another in clinic follow up for further investigation.The patient was stable and will continue being monitored.

Manufacturer Narrative

The reported event of inability to communicate via bluetooth (ble) was confirmed.Based on the review of the information provided, it was confirmed that a memory corruption had occurred, resulting in the loss of ble connectivity.

Event Description

Additional information was received indicating reprogramming was performed to resolve the event.The patient was stable.

• Brand Name: GALLANT DR
• Type of Device: NO MATCH
• Manufacturer (Section D): ABBOTT; 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ABBOTT; 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: richard williamson ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 18405383
• MDR Text Key: 331484832
• Report Number: 2017865-2023-95663
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 05415067032003
• UDI-Public: 05415067032003
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P030054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 01/30/2024

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
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2022
• Device Model Number: CDDRA500Q
• Device Lot Number: S000076670
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/15/2023
• Initial Date FDA Received: 12/27/2023
• Supplement Dates Manufacturer Received: 01/13/2024; 01/17/2024
• Supplement Dates FDA Received: 01/16/2024; 01/30/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/14/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1