MAUDE Adverse Event Report: IRHYTHM TECHNOLOGIES, INC ZIO XT; RECORDER, MAGNETIC TAPE, MEDICAL

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Skin Infection (4544)

Event Date 04/15/2023

Event Type  Injury  

Manufacturer Narrative

The patient reported that they developed an infection due to an injury sustained during the skin-prep process which precedes device application.The patient sought treatment from a physician and was prescribed antibiotics for infection and steroids.The device¿s clinical reference manual, application instructions ((b)(4)) reads as follows: ¿prepare the patient¿s skin using the materials from the skin prep & placement kit: a.Remove the razor by holding the cover on the sides and pulling down on the handle (fig.D).Shave the placement area.Do not add pressure to the razor; shave across the skin lightly.Note: if a cut should occur, treat the site and only continue once bleeding has stopped.After it has stopped, do not place electrode over cut.Note: dispose of razor in proper sharps container.B.Applying pressure, abrade the entire area using 40 broad strokes (fig.E).Note: be sure to abrade the full prep area.C.Using all alcohol pads, clean the area thoroughly.Allow skin to dry for 1 minute.At application, any hair, skin oil, residue or moisture present can interfere with the duration and quality of the test.¿ in addition, device manual warnings section read as follows: do not use the zio xt 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 xt patch from the patient¿s chest.The reported issue has been attributed to use error.The account manager has been notified to conduct training.

Event Description

The patient reported skin irritation with signs of secondary infection caused by the skin preparation procedures for the application of the zio xt.The patients¿ healthcare provider prescribed antibiotics and steroids to treat the affected area.

• Brand Name: ZIO XT
• Type of Device: RECORDER, MAGNETIC TAPE, MEDICAL
• 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 90630
• Manufacturer Contact: mazi kiani ; 699 8th st suite 600; san francisco, CA 94103 ; 9494132147
• MDR Report Key: 16907903
• MDR Text Key: 314973074
• Report Number: 3007208829-2023-00028
• Device Sequence Number: 1
• Product Code: DSH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121319
• 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
• Report Date: 04/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Expiration Date: 08/21/2023
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/21/2023
• Date Manufacturer Received: 04/15/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/22/2023
• 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): Required Intervention
• Patient Age: 59 YR
• Patient Sex: Female