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

Model Number HT900

Device Problems High Readings (2459); Output Problem (3005)

Patient Problem Low Blood Pressure/ Hypotension (1914)

Event Date 11/17/2022

Event Type  malfunction  

Event Description

Patient reported that their livongo blood pressure monitor was reading 10-15 points higher.Patient adjusted their medication due to the livongo blood pressure monitor readings.Patient stated due to the livongo readings they slightly overmedicated and became dizzy.

Manufacturer Narrative

The blood pressure monitor was requested from the patient but has not yet been returned.If the device is retuned an investigation will be conducted and a supplemental report will be filed.This report is being filed due to the patient stating that the livongo blood pressure monitor was producing unusually high readings and the patient adjusted their medication causing dizziness.The patient did not report any medical intervention due to the experienced dizziness.

• Brand Name: LIVONGO BLOOD PRESSURE MONITOR
• Type of Device: BLOOD 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: jacob gendler ; 150 w evelyn ave; suite 150; mountain view, CA 94041 ; 6124184648
• MDR Report Key: 16091008
• MDR Text Key: 308502246
• Report Number: 3011196194-2022-00035
• Device Sequence Number: 1
• Product Code: DXN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K170196
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 12/20/2022

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 Model Number: HT900
• Device Catalogue Number: OFG15760
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/03/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 63 YR
• Patient Sex: Female