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

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem Insufficient Information (4580)

Event Date 01/27/2022

Event Type  malfunction  

Manufacturer Narrative

At the conclusion of the investigation, it was determined that the cause of the incorrect findings was due to the certified cardiographic technician (cct) misclassifying the arrhythmia.A corrected report was submitted to the account and the cct was retrained as a result.The report provided does not provide diagnosis; rather it provides preliminary findings from which the clinician may make a diagnosis based on clinical judgement and patient clinical history.

Event Description

An ecg result was provided to the physician that was incorrect; as a result, the patient was treated based on the incorrect finding.Information regarding patient impact resulting from the treatment was not provided.

• Brand Name: ZIO AT PATCH
• 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; 11085 knott avenue suite b; cypress CA 90630
• Manufacturer Contact: mazi kiani ; 699 8th st suite 600; san francisco, CA 94103 ; 9494132147
• MDR Report Key: 13591940
• MDR Text Key: 286472226
• Report Number: 3007208829-2022-00003
• 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: Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 01/27/2022

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 Expiration Date: 06/12/2022
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/27/2022
• Initial Date FDA Received: 02/24/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/14/2021
• 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: 85 YR
• Patient Sex: Male