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

Model Number BG300C

Device Problem Temperature Problem (3022)

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

Event Date 12/23/2021

Event Type  malfunction  

Manufacturer Narrative

The meter was requested for return to the manufacturer for investigation.However, we have not received the device back for investigation.No injury to the user was reported.

Event Description

The member complaint of the back of the meter swell and curved up.The battery looks swollen.

• 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: 13122217
• MDR Text Key: 287585808
• Report Number: 3011196194-2021-00025
• 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
• Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 12/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: BG300C
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No
• 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: 58 YR
• Patient Sex: Female