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

Model Number UA-651BLE-LIV

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); High Readings (2459)

Patient Problem High Blood Pressure/ Hypertension (1908)

Event Date 12/05/2022

Event Type  malfunction  

Event Description

The patient stated that she got a reading of 222/138 from the livongo blood pressure monitor and her physician advised her to go to the emergency room.At the emergency room, they got a reading of 169/104.We were unable to determine if there was any medical intervention that took place after this.

Manufacturer Narrative

Multiple attempts were made to contact the member with no success.The device was not returned.

• Brand Name: LIVONGO BLOOD PRESSURE MONITOR
• Type of Device: HYPERTENSION MONITOR
• Manufacturer (Section D): LIVONGO HEALTH, INC.; 150 w evelyn ave; unit 150; mountain view CA 94041
• Manufacturer (Section G): LIVONGO HEALTH; 150 w evelyn ave; unit 150; mountain view CA 94041
• Manufacturer Contact: jacob gendler ; 150 w evelyn ave; unit 150; mountain view, CA 94041
• MDR Report Key: 16132050
• MDR Text Key: 307032620
• Report Number: 3011196194-2023-00001
• Device Sequence Number: 1
• Product Code: DXN
• Combination Product (y/n): N
• PMA/PMN Number: K170196
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: UA-651BLE-LIV
• Device Catalogue Number: OFG101779
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 53 YR