• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LIVONGO HEALTH INC LIVONGO BLOOD PRESSURE MONITOR

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

LIVONGO HEALTH INC LIVONGO BLOOD PRESSURE MONITOR Back to Search Results
Model Number HT900
Device Problem Incorrect Measurement (1383)
Patient Problem Hyperglycemia (1905)
Event Date 03/14/2021
Event Type  malfunction  
Manufacturer Narrative
The hypertension monitor has not been returned to the manufacturer. An investigation will be performed but has not yet begun. A follow-up report will be submitted upon completion of the investigation.
 
Event Description
Patient reported that she had received inaccurate readings from her hypertension device. She had gone to the emergency room which found that her hypertension monitor was reading high but her blood pressure was actually low due to her medication being adjusted incorrectly because of the readings on her hypertension device.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameLIVONGO BLOOD PRESSURE MONITOR
Type of DeviceBLOOD PRESSURE MONITOR
Manufacturer (Section D)
LIVONGO HEALTH INC
150 w. evelyn ave
suite 150
mountain view CA 94041
Manufacturer (Section G)
LIVONGO HEALTH INC
150 w. evelyn ave
suite 150
mountain view CA 94041
Manufacturer Contact
michael chibbaro
150 w. evelyn ave
suite 150
mountain view, CA 94041
MDR Report Key11832084
MDR Text Key253846273
Report Number3011196194-2021-00009
Device Sequence Number1
Product Code DXN
Combination Product (y/n)N
PMA/PMN Number
K131395
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Remedial Action Replace
Type of Report Initial
Report Date 05/06/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/17/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberHT900
Device Catalogue NumberOFG05191
Was Device Available for Evaluation? No Answer Provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

-
-