MAUDE Adverse Event Report: LIVONGO HEALTH LIVONGO BLOOD GLUCOSE MONITORING SYSTEM; GLUCOSE OXIDASE, GLUCOSE

Model Number BG300

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem Insufficient Information (4580)

Event Date 11/08/2021

Event Type  malfunction  

Event Description

A few months ago i started using the livongo blood glucose monitoring system to help manage my type ii diabetes.A week ago, i started a two week trial using the freestyle libre 2 flash glucose monitoring system.When i compared the readings from the two, the libre was consistently measuring 40-50 mg/dl higher than the livongo.I know the readings vary some based on the different technique used to measure value.Since the average value of the libre corresponds to the approximate a1c from my last blood test, i suspected the livongo was incorrect.I still had my old onetouch ultra 2 monitor.When i used it, the value was consistent with the libre.Three examples i measured were: yesterday before lunch: livongo 77, libre 115, onetouch 131 yesterday before dinner: livongo 149, libre 193, onetouch 209 this morning before breakfast: livongo 105, libre 152, onetouch 150 first two readings, the libre was showing a downward trend which is consistent with the onetouch being slightly higher.Fda safety report id # (b)(4).

• Brand Name: LIVONGO BLOOD GLUCOSE MONITORING SYSTEM
• Type of Device: GLUCOSE OXIDASE, GLUCOSE
• Manufacturer (Section D): LIVONGO HEALTH
• MDR Report Key: 12804230
• MDR Text Key: 280933761
• Report Number: MW5105278
• Device Sequence Number: 1
• Product Code: CGA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 11/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: BG300
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 52 YR
• Patient Sex: Male
• Patient Weight: 98 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White