MAUDE Adverse Event Report: ACON LABORATORIES, INC/LIVONGO HEALTH LIVONGO BLOOD GLUCOSE MONITORING SYSTEM; SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER

Model Number	BG300
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/11/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
Livongo glucose monitor issues.Blood glucose strips will not absorb blood.The meter can not read the strips.I have tried 8 strips in a session and can not get results.I have tried different lots of the strips but they do not absorb blood.It takes me 5 to ten attempts to get a reading.Tried different angles to no avail.The manufacturer has sent replacement strips but same outcome.Unable to determine if it's the strips or monitor.Fda safety report id # (b)(4).

• Brand Name: LIVONGO BLOOD GLUCOSE MONITORING SYSTEM
• Common Device Name: SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER
• Manufacturer (Section D): ACON LABORATORIES, INC/LIVONGO HEALTH
• MDR Report Key: 10843181
• Report Number: MW5097874
• Device Sequence Number: 1153980
• Product Code: NBW
• UDI-Device Identifier: 00853553005004
• UDI-Public: (01)00853553005004
• Initial Reporter State: VA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Patient
• Type of Report: Initial
• Report Date (Section B): 11/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 11/21/2021
• Device Model Number: BG300
• Device Catalogue Number: OFG00406
• Device Lot Number: 890973
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/13/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 62 YR
• Patient Weight: 84