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

Model Number BG300C

Device Problems Low Test Results (2458); Insufficient Information (3190)

Patient Problem Hyperglycemia (1905)

Event Date 01/05/2024

Event Type  Injury  

Manufacturer Narrative

Review of the test data suggests that the test strip vial may have been open for over 6 months, rendering them expired.The patient did not disclose information regarding the expiration date of the test strips or when the vial was open.The device associated with this incident was not returned for investigation.If the device is returned an investigation will be conducted and a supplemental report will be filed.

Event Description

The patient reported receiving readings in the 30s and 40s while using their livongo blood glucose meter.The patient also tested with another livongo meter and reported that results were within normal limits.The patient self-treated with orange juice and glucose gel.The member's reading in the hospital was over 300 and the livongo meter read 38.The hospital gave the patient an iv to express blood in their vein but did not provide any medication to lower their blood glucose level but did have the patient walking to help flush glucose out of their system.

• Brand Name: LIVONGO BLOOD GLUCOSE METER
• Type of Device: BLOOD GLUCOSE METER
• Manufacturer (Section D): TELADOC HEALTH INC.; 560 s. winchester ave.; suite 400; san jose CA 95128
• Manufacturer (Section G): TELADOC HEALTH INC.; 560 s. winchester ave.; suite 400; san jose CA 95128
• Manufacturer Contact: jacob gendler ; 560 s. winchester ave.; suite 400; san jose, CA 95128
• MDR Report Key: 18597559
• MDR Text Key: 334029544
• Report Number: 3011196194-2024-00005
• 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: 01/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: BG300C
• Device Catalogue Number: FG11917
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 50 YR