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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: IRHYTHM TECHNOLOGIES, INC ZIO XT PATCH; ZIO PATCH
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IRHYTHM TECHNOLOGIES, INC ZIO XT PATCH; ZIO PATCH Back to Search Results
Device Problem False Negative Result (1225)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/05/2019
Event Type  malfunction  
Manufacturer Narrative
At the conclusion of the investigation, the reported false negative was confirmed.The root cause of the issue is attributed to human error, misinterpretation of the ecg data.The ecg report was corrected.
 
Event Description
Irhythm was contacted by the physician who stated that the final report was missing an atrial fibrillation finding.
 
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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 Key8551134
MDR Text Key145941249
Report Number3007208829-2019-00028
Device Sequence Number1
Product Code DSH
UDI-Device Identifier00869770000203
UDI-Public00869770000203
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K121319
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 04/05/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date08/19/2019
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/23/2019
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 04/05/2019
Initial Date FDA Received04/25/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/20/2019
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
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