MAUDE Adverse Event Report: TRIVIDIA HEALTH, INC. N/A; BLOOD GLUCOSE SYSTEM

Model Number N/A

Device Problem Off-Label Use (1494)

Patient Problem Burning Sensation (2146)

Event Date 11/14/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Product not returned for evaluation.No replacement product needed at this time.Most likely underlying root cause: mlc-61- improper use / mishandled by end user note: manufacturer contacted customer (several attempts) in a follow-up call in order to ensure the customer's condition since the initial call - unable to establish contact with the customer at this time.

Event Description

Consumer reported complaint for accidently using control solution as eye drops in both eyes.Girlfriend is calling on behalf of the customer.The customer did report symptom of stinging/burning in eyes.Medical attention is not reported as a result of the actual blood glucose results and reported symptoms.The product storage location is undisclosed.The test control lot manufacturer's expiration date is undisclosed and open vial date is undisclosed.Girlfriend states that by accident he put the control solution in his eyes, he thought it was his eyes drops.Customer states that his eye is stinging him, burning him.Customer have been washing his eyes with cold water, but his eyes are not red.Customer did put it in both eye.This happen yesterday.Customer states that he lives out of the country.She did not want to provide any further assistance.She states that she had to go, she will contact her boyfriend to seek medical assistance.Unable to verify the lot # of the control solution.

• Brand Name: N/A
• Type of Device: BLOOD GLUCOSE SYSTEM
• Manufacturer (Section D): TRIVIDIA HEALTH, INC.; 2400 nw 55th court; fort lauderdale FL 33309
• Manufacturer Contact: karen devincent ; 2400 nw 55th court; fort lauderdale, FL 33309 ; 954677-920
• MDR Report Key: 8142524
• MDR Text Key: 130040200
• Report Number: 1000113657-2018-01231
• Device Sequence Number: 1
• Product Code: NBW
• Combination Product (y/n): N
• PMA/PMN Number: K000000
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 12/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Event Location: Home
• Date Manufacturer Received: 11/14/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1