MAUDE Adverse Event Report: LIVONGO HEALTH INC LIVONGO BLOOD GLUCOSE METER

Model Number BG300C

Device Problems Failure to Charge (1085); Smoking (1585)

Patient Problem No Patient Involvement (2645)

Event Date 05/20/2020

Event Type  malfunction  

Manufacturer Narrative

The meter was requested for return to the manufacturer for investigation.Should the device be returned for investigation, a supplemental report will be filed with the investigation results.

Event Description

The patient reported that their bg meter was not holding a charge using the charger provided by livongo.Patient then reported that they used a different charger to attempt to charge their meter to no avail.Patient reported that upon removing the non-livongo charger, their meter was warm to the touch and smoking.

• Brand Name: LIVONGO BLOOD GLUCOSE METER
• Type of Device: BLOOD GLUCOSE METER
• Manufacturer (Section D): LIVONGO HEALTH INC; 150 w. evelyn ave; suite 150; mountain view, ca
• Manufacturer (Section G): LIVONGO HEALTH INC; 150 w. evelyn ave; suite 150; mountain view,
• Manufacturer Contact: michael chibbaro ; 150 w. evelyn ave; suite 150; mountain view, ca ; 7185657
• MDR Report Key: 10185834
• MDR Text Key: 196139428
• Report Number: 3011196194-2020-00025
• Device Sequence Number: 1
• Product Code: NBW
• Combination Product (y/n): N
• PMA/PMN Number: K133584
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial
• Report Date: 06/23/2020

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: No Information
• Device Model Number: BG300C
• Device Catalogue Number: FG00408
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/23/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/04/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 50 YR