MAUDE Adverse Event Report: TELADOC HEALTH LIVONGO TEST STRIPS; GLUCOSE OXIDASE

Lot Number 800495OFG00406

Device Problem High Test Results (2457)

Patient Problem Hypoglycemia (1912)

Event Date 02/26/2024

Event Type  Injury  

Event Description

Patent reported that they woke up not feeling well and sweating, when they tested with their livongo meter, they received a result of 128, however went to the er based off how they were feeling.30 minutes after arrival at the er, the patients bg was tested using the hospital meter, and resulted in a reading of 58.The patient was given soda and admitted to be monitored, and released the next day.

Manufacturer Narrative

After speaking to the patient about this incident it was found that the patient was storing their test strips incorrectly, causing them to prematurely expire.Due to using expired test strips, the patient may have received a falsely high reading.The patient was provided with new test strips and informed of proper storage and usage.

• Brand Name: LIVONGO TEST STRIPS
• Type of Device: GLUCOSE OXIDASE
• Manufacturer (Section D): TELADOC HEALTH; 560 s. winchester ave.; suite 400; san jose CA 95128
• Manufacturer (Section G): TELADOC HEALTH; 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: 18977266
• MDR Text Key: 338557134
• Report Number: 3011196194-2024-00018
• 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
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 03/25/2024

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 Lot Number: 800495OFG00406
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/26/2024
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 78 YR