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

Catalog Number	FG11917
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Ecchymosis (1818)
Date of Event	03/06/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device associated with this report was disposed of, therefore root cause of the failure is unable to be determined.
Event or Problem Description
The patient reported plastic particles from the lancing device went under her skin several times.The patient removed the particles using tweezers and or a needle.The patient reported there was very slight discoloration of her skin, however, the patient did not seek medical attention.

• Brand Name: LIVONGO LANCING DEVICE
• Common Device Name: LANCING DEVICE
• Manufacturer (Section D): TELADOC HEALTH, INC; 560 s. winchester blvd; suite 400; san jose CA 95128
• Manufacturer (Section G): TELADOC HEALTH, INC.; 560 s. winchester blvd.; suite 400; san jose CA 95128
• Manufacturer Contact: jacob gendler ; 560 s. winchester blvd.; suite 400; san jose, CA 95128
• MDR Report Key: 18990592
• Report Number: 3011196194-2024-00019
• Device Sequence Number: 18040033
• Product Code: NBW
• 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): 03/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: FG11917
• 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: 03/28/2024
• 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
• Patient Age: 76 YR
• Patient Sex: Unknown