ZIO XT PATCH N100A102X

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2020-02-05 for ZIO XT PATCH N100A102X manufactured by Irhythm Technologies, Inc.

Event Text Entries

[177805698] At the conclusion of the investigation, the reported event was confirmed. The probable cause is likely due to a user error that occurred while registering the device to the appropriate patient during the device application process.
Patient Sequence No: 1, Text Type: N, H10


[177805699] It was reported that two patient's devices were swapped during the patient registration process by the healthcare provider. As a result, an incorrect ecg report provided to the physician resulted in treatment to the incorrect patient.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3007208829-2020-00002
MDR Report Key9670989
Report SourceUSER FACILITY
Date Received2020-02-05
Date of Report2019-10-11
Date of Event2019-10-02
Date Mfgr Received2019-10-11
Device Manufacturer Date2019-08-28
Date Added to Maude2020-02-05
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMR. RICH LAGUNA
Manufacturer Street699 8TH ST SUITE 600
Manufacturer CitySAN FRANCISCO CA 94103
Manufacturer CountryUS
Manufacturer Postal94103
Manufacturer Phone4156325749
Manufacturer G1IRHYTHM TECH, INC
Manufacturer Street11085 KNOTT AVENUE SUITE B
Manufacturer CityCYPRESS CA 90630
Manufacturer CountryUS
Manufacturer Postal Code90630
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameZIO XT PATCH
Generic NameZIO PATCH
Product CodeDSH
Date Received2020-02-05
Model NumberN100A102X
Device Expiration Date2020-02-24
OperatorLAY USER/PATIENT
Device Availability*
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerIRHYTHM TECHNOLOGIES, INC
Manufacturer Address699 8TH ST SUITE 600 SAN FRANCISCO CA 94103 US 94103


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2020-02-05

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