MAUDE Adverse Event Report: TRIVIDIA HEALTH INC TRUE METRIX; SYSTEM, TEST BLOOD GLUCOSE, OVER THE COUNTER

Model Number CONTROL, TRUE METRIX L1

Device Problem Use of Device Problem (1670)

Patient Problem Red Eye(s) (2038)

Event Date 12/12/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Most likely underlying root cause: mlc-28: there was not enough information to determine the mlurc.Manufacturer contacted customer in a follow-up call to ensure that the customer's condition improved - unable to establish contact with customer at this time.No product notification letter sent since no customer address on file.

Event Description

Consumer reported complaint for mistakenly using control solution as eye drop in both eyes.Customer stated that she has an eye infection and her eyes were already red but when she applied the eye drops to both eyes, it made it redder.Customer flushed her eyes with water for a few minutes and then applied her eye drops that she uses for her infection.Customer stated that her eyes are slowly clearing up.The customer did report symptoms.Customer contacted her physician and is awaiting call back for further assistance.Customer does not have another other symptoms of negative reaction.The product storage location is undisclosed.The control solution lot# 7bc1b23.Manufacturer¿s expiration date is 10/31/2019 and open vial date is undisclosed.

• Brand Name: TRUE METRIX
• Type of Device: SYSTEM, TEST BLOOD GLUCOSE, OVER THE COUNTER
• 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
• MDR Report Key: 9559865
• MDR Text Key: 185753138
• Report Number: 1000113657-2020-00008
• Device Sequence Number: 1
• Product Code: NBW
• UDI-Device Identifier: 021292008390
• UDI-Public: (01)021292008390
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 01/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/31/2019
• Device Model Number: CONTROL, TRUE METRIX L1
• Device Lot Number: 7BC1B23
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 12/12/2019
• Date Manufacturer Received: 12/12/2019
• 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