MAUDE Adverse Event Report: ACTIGRAPH, LLC ACTIGRAPH GT9X LINK; EXERCISER, MEASURING

Model Number GT9X LINK

Device Problem Corroded (1131)

Patient Problems Reaction (2414); Partial thickness (Second Degree) Burn (2694)

Event Date 06/05/2019

Event Type  No Answer Provided  

Event Description

Actigraph received info from a customer that a participant experienced a skin reaction on "burn" under the metal electrical contacts of a device.This device was not worn in the normal fashion, the wrist holster, but instead physically secured to the user's chest via a tegaderm patch for 48 hours.The display of the device was facing out and the device contact pins were directly touching the skin.The customer reported, the electrodes [on the back of the device] were clearly corroded and there was a greenish patina on / in the participant's skin.The participant also reported the "device felt warm (even indoors in ac)." however, the reporter clarified that it was not a heat related injury, but speculated it appeared to be more of a chemical and / or electrical reaction with metal contacts; specifically the leftmost electrode.The participant reported they sought medical treatment and the physician described the reaction as a "2nd degree burn" and prescribed an antibiotic topical ointment.It was reported to actigraph that a second participant within the same study notified them of having similar sores but was much less severe and they did not seek medical attention; it should be noted this participant was using the device in the same manner.No further pt complications have been reported as a result of this event.The instructions for use of the actigraph gt9x link informs the user to insert the device into the holster and then attach to the wrist or waist during use.In this event, the gt9x link was not put into a holster, but instead physically secured to the user's chest via a tegaderm patch for 48 hours.We advised the reporting organization to not deploy the device in this fashion.This device has been in the field for years with no similar reports.Actigraph did not review any medical records.The physical devices have been returned to actigraph.There is no way to determine the exact cause of skin reactions by analysis of the physical, but a physical product analysis and independent chemical analysis will be performed to investigate any potential chemical which may cause corrosion.The independent chemical analysis is currently ongoing and a supplemental report will be issued if necessary.Fda safety report id# (b)(4).

• Brand Name: ACTIGRAPH GT9X LINK
• Type of Device: EXERCISER, MEASURING
• Manufacturer (Section D): ACTIGRAPH, LLC; pensacola FL 32502
• MDR Report Key: 8760345
• MDR Text Key: 150418304
• Report Number: MW5087861
• Device Sequence Number: 1
• Product Code: ISD
• UDI-Device Identifier: 00853048008015
• UDI-Public: (01)00853048008015
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 06/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: GT9X LINK
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2019
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 29 YR
• Patient Weight: 66