MAUDE Adverse Event Report: TELADOC HEALTH INC. LIVONGO LANCING DEVICE

Catalog Number	OFG00404
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	07/01/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 or Problem Description
The patient reported an infection after puncturing their skin with their lancing device.The patient went to the emergency room to seek medical attention due to a fever, but didn't provide details of the medical treatment received.

• Brand Name: LIVONGO LANCING DEVICE
• Common Device Name: LANCING DEVICE
• 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 95128
• Manufacturer Contact: jacob gendler ; 560 s. winchester ave; suite 400; san jose 95128
• MDR Report Key: 19806026
• Report Number: 3011196194-2024-00035
• Device Sequence Number: 8379523
• Product Code: QRK
• UDI-Device Identifier: 00853553005219
• UDI-Public: 00853553005219
• Combination Product (Y/N): N
• PMA/510(K) Number: K133584
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 07/22/2024

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?: No
• Device Catalogue Number: OFG00404
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 68 YR
• Patient Sex: Unknown