MAUDE Adverse Event Report: TRIVIDIA HEALTH, INC. TRUEMETRIX; BLOOD GLUCOSE SYSTEM

Model Number	TRUEMETRIX
Medical Device Problem Codes	High Test Results (2457); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hyperglycemia (1905); Blurred Vision (2137); Urinary Frequency / Polyuria (2275)
Date of Event	08/17/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Product not yet returned for evaluation.Most likely underlying root cause: mlc-18- user has high glucose value test strip udi# (b)(4).Note: manufacturer contacted customer on (b)(4) 2018 in a follow-up call to ensure the customer's condition since the initial call; customer condition has not improved and is still experiencing same symptoms.He did seek medical attention and was treated for hyperglycemia.Dates and exact treatment are undisclosed.Customer states meter read 500mg/dl.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 or Problem Description
Consumer reported complaint for hi display accompanied by symptoms.The expected fasting blood glucose test result range is undisclosed.The report symptoms of excessive thirst, frequent urination, sleepy, often hungry, and blurry vision.Medical attention is not reported as a result of the actual blood glucose results and reported symptoms.The product storage location is undisclosed.During the call on (b)(6) 2018, a blood test was performed by customer and produced test results of 585mg/dl using true metrix meter.The test strip lot manufacturer's expiration date is 06/27/2019 and open vial date is undisclosed.The meter memory was not reviewed for previous test result history.Instructed customer to go to the hospital.Customer states he will go to the hospital.Customer cannot continue the troubleshooting.

• Brand Name: TRUEMETRIX
• Common Device Name: BLOOD GLUCOSE SYSTEM
• Manufacturer (Section D): TRIVIDIA HEALTH, INC.; 2400 nw 55th court; fort lauderdale FL 33309
• MDR Report Key: 7852922
• Report Number: 1000113657-2018-00930
• Device Sequence Number: 1966814
• Product Code: NBW
• UDI-Device Identifier: 00021292006068
• UDI-Public: (01)00021292006068
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• PMA/510(K) Number: K140100
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 09/06/2018

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
• Operator of Device: Lay User/Patient
• Device Model Number: TRUEMETRIX
• Device Catalogue Number: RE4H01-81
• Device Lot Number: MV2726
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Event Location: Home
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/17/2018
• Initial Report FDA Received Date: 09/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1