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

Model Number BG300C

Device Problem Overheating of Device (1437)

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

Event Date 09/14/2020

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 customer reported that their livongo blood glucose meter started to spark 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
• MDR Report Key: 10653073
• MDR Text Key: 219178788
• Report Number: 3011196194-2020-00037
• 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: 10/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2020
• 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 Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 77 YR