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

Model Number	TRUEMETRIX
Medical Device Problem Codes	High Test Results (2457); Device Displays Incorrect Message (2591)
Health Effect - Clinical Codes	Fatigue (1849); Hyperglycemia (1905)
Date of Event	03/14/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Product not yet returned for evaluation.Most likely underlying root cause: mlc-33-ambient temperature out of operating range.(b)(4).Manufacturer contacted customer on (b)(6) 2018 in a follow-up call in order to ensure the customer's condition since the initial call; from the time of initial contact, customer's condition has improved and they are no longer experiencing symptoms.Customer did, however, seek medical attention.Customer was hospitalized on (b)(6) 2018 for hypertension and hyperglycemia (600mg/dl fasting) and was treated with insulin injection, metformin and potassium.Customer was discharged on (b)(6) 2018.
Event or Problem Description
Consumer reported complaint for e-1 accompanied by hi and symptoms.The expected fasting blood glucose test result range is undisclosed.The customer did report symptoms of fatigue.Medical attention is reported as a result of the actual blood glucose results and reported symptoms.The product is not stored by customer according to specification in extreme cold temperature.During the call on (b)(6) 2018, a blood test was performed fasting by the customer and produced test results of hi using true metrix meter.The test strip lot manufacturer's expiration date is 12/31/2018 and open vial date is (b)(6) 2018.The meter memory was not reviewed for previous test result history.

• 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: 7402510
• Report Number: 1000113657-2018-00406
• Device Sequence Number: 37673
• Product Code: NBW
• UDI-Device Identifier: 00096295126600
• UDI-Public: (01)00096295126600
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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): 04/06/2018

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: MU2537
• 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: 03/14/2018
• Initial Report FDA Received Date: 04/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization