MAUDE Adverse Event Report: TELADOC HEALTH, INC LIVONGO TEST STRIPS; BLOOD GLUCOSE TEST STRIPS

Catalog Number OFG00406

Device Problem Incorrect Measurement (1383)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/18/2023

Event Type  malfunction  

Event Description

Patient reported that they were unable to calibrate their device.When performing control solution testing, the member received the following results: control solution 1: range - 102-153., results - 70, and 79; control solution 2 range - 275-413, results - 258, and 252.

Manufacturer Narrative

The test strips and control solution associated with this report were not returned for testing.Review of the dhr for both the test strips and control solution used at the time of the event was performed and no non-conformances were noted.Root cause of the patient receiving out of range control solution tests was unable to be determined.The blood glucose meter that was used at the time of the event was returned for investigation, and testing was performed.Testing was able to be completed successfully, with no issues noted.

• Brand Name: LIVONGO TEST STRIPS
• Type of Device: BLOOD GLUCOSE TEST STRIPS
• Manufacturer (Section D): TELADOC HEALTH, INC; 150 w. evelyn ave; suite 150; mountain view CA 94041
• Manufacturer (Section G): TELADOC HEALTH, INC; 150 w. evelyn ave; suite 150; mountain view CA 94041
• Manufacturer Contact: jacob gendler ; 150 w evelyn ave; suite 150; mtn. view, CA 94041 ; 6124184648
• MDR Report Key: 17962091
• MDR Text Key: 326157386
• Report Number: 3011196194-2023-00090
• Device Sequence Number: 1
• Product Code: CGA
• 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
• Type of Report: Initial
• Report Date: 10/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/03/2024
• Device Catalogue Number: OFG00406
• Device Lot Number: 800307
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 66 YR