MAUDE Adverse Event Report: IRHYTHM TECHNOLOGIES, INC ZIO XT PATCH; ZIO PATCH

Device Problem Use of Device Problem (1670)

Patient Problem No Code Available (3191)

Event Date 08/07/2017

Event Type  Injury  

Manufacturer Narrative

At the conclusion of the investigation, the reported incorrect patient posted to report resulting in incorrect treatment was confirmed.The root cause seems to be user related.The representative at the user facility who registered the patients swapped the device serial number resulting in the wrong patient being associated with the final report.

Event Description

It was reported that during registration of the patient to device, two patients had their serial number switched resulting in the report posting to the incorrect patient and one patient receiving incorrect treatment.

• Brand Name: ZIO XT PATCH
• Type of Device: ZIO PATCH
• Manufacturer (Section D): IRHYTHM TECHNOLOGIES, INC; 650 townsend; suite 500; san francisco CA 94103
• Manufacturer (Section G): IRHYTHM TECH, INC; 11085 knott avenue; suite b; cypress CA 90630
• Manufacturer Contact: rich laguna ; 650 townsend; suite 500; san francisco, CA 94103 ; 4156325749
• MDR Report Key: 8901513
• MDR Text Key: 154559973
• Report Number: 3007208829-2019-00055
• Device Sequence Number: 1
• Product Code: DSH
• UDI-Device Identifier: 00869770000203
• UDI-Public: 00869770000203
• 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: user facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 08/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/10/2017
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/14/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/07/2017
• Initial Date FDA Received: 08/16/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/13/2017
• 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: 69 YR