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

Model Number BG300

Device Problem Overheating of Device (1437)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/12/2020

Event Type  malfunction  

Manufacturer Narrative

The bg meter have not been returned to the manufacturer.Should the device be returned, a supplemental report will be filed with the results of the testing.

Event Description

The patient reported that their livongo blood glucose meter smelled like it was burning when they were charging it.

• 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 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 ; 4087185657
• MDR Report Key: 10523548
• MDR Text Key: 209208974
• Report Number: 3011196194-2020-00035
• 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
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 09/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: BG300
• Device Catalogue Number: FG00408
• 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 Age: 48 YR