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

Model Number HT900

Device Problem High Readings (2459)

Patient Problem Low Blood Pressure/ Hypotension (1914)

Event Date 05/27/2022

Event Type  malfunction  

Manufacturer Narrative

Device requested for return evaluation.Patient unable to locate device.If the device is returned, the device will be tested.

Event Description

Patient was hospitalized after receiving a high blood pressure reading and administering medication based on a reading they received from their livongo blood pressure monitor.Patient taken to the hospital and the patient was given medication to raise their heart rate to raise their heart rate.Patient was hospitalized from on (b)(6) 2022 to on (b)(6) 2022 in result of the incident.

• 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: 15259522
• MDR Text Key: 305419931
• Report Number: 3011196194-2022-00012
• Device Sequence Number: 1
• Product Code: DXN
• Combination Product (y/n): N
• PMA/PMN Number: K131395
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 08/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: HT900
• Device Catalogue Number: OFG05191
• 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
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Hospitalization
• Patient Age: 67 YR
• Patient Sex: Male