MAUDE Adverse Event Report: IRHYTHM TECHNOLOGIES, INC ZIO AT; DETECTOR AND ALARM, ARRHYTHMIA

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Fever (1858); Skin Inflammation/ Irritation (4545)

Event Date 05/30/2023

Event Type  Injury  

Event Description

The patient reported skin irritation and an allergic reaction from wearing the zio xt patch.Additionally, the patient felt ill and had a fever.The patient was unsure if the symptoms were related to the skin irritation/allergic reaction as the patient is immunocompromised.

Manufacturer Narrative

The patient reported skin irritation and allergic reaction from wearing the zio xt patch.The patient, who stated they are immunocompromised, also reported they were presenting with a fever and felt ill.Multiple attempts were made to contact the patient to obtain additional information; however, the patient could not be reached.The returned product was evaluated and successfully produced a clinical report.The device passed functional verification testing during the manufacturing process.Skin irritation is a known inherent risk of the device.Device manual warnings section read as follows: do not use the zio at patch on patients with known allergic reaction to adhesives or hydrogels or with family history of adhesive skin allergies.¿if skin irritation such as severe redness, itching or allergic symptoms develop, remove the zio at patch from the patient¿s chest.

Event Description

The patient reported skin irritation and an allergic reaction from wearing the zio at patch.Additionally, the patient felt ill and had a fever.The patient was unsure if the symptoms were related to the skin irritation/allergic reaction as the patient is immunocompromised.

• Brand Name: ZIO AT
• Type of Device: DETECTOR AND ALARM, ARRHYTHMIA
• Manufacturer (Section D): IRHYTHM TECHNOLOGIES, INC; 699 8th st. suite 600; san francisco CA 94103
• Manufacturer (Section G): IRHYTHM TECHNOLOGIES, INC; 6550 katella avenue, suite 200; cypress CA
• Manufacturer Contact: mazi kiani ; 699 8th st suite 600; san francisco, CA 94103 ; 9494132147
• MDR Report Key: 17213923
• MDR Text Key: 317986067
• Report Number: 3007208829-2023-00033
• Device Sequence Number: 1
• Product Code: DSI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K163512
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 07/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Expiration Date: 10/25/2023
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/03/2023
• Date Manufacturer Received: 07/19/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/28/2023
• 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
• Patient Outcome(s): Other
• Patient Age: 50 YR
• Patient Sex: Female