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

Model Number	TRUETRACK
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Codes	Fatigue (1849); Polydipsia (2604)
Date of Event	06/08/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Product not returned for evaluation.No replacement product needed at this time.Customer was not feeling well and will seek medical attention.Unable to complete phone call.Most likely underlying root cause: mlc-18- user has high glucose value 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.Product notification letter sent to customer to contact customer care.
Event or Problem Description
Consumer reported complaint for high blood glucose results accompanied by symptoms.The customer is concerned with results obtained of 451mg/dl.The expected fasting blood glucose test result range is undisclosed.The customer did report symptoms of feeling fatigue and excessive thirst.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 fasting by the customer and produced test results of 451mg/dl using true track meter.The test strip lot manufacturer's expiration date is 07/19/2020 and open vial date is undisclosed.The meter memory was not reviewed for previous test result history.Only conducted one glucose test at time of call due to symptoms and result was 451mg/dl fasting.Customer was not feeling well and will seek medical attention.

• Brand Name: TRUETRACK
• Common Device Name: BLOOD GLUCOSE SYSTEM
• Manufacturer (Section D): TRIVIDIA HEALTH, INC.; 2400 nw 55th court; fort lauderdale FL 33309
• MDR Report Key: 7659809
• Report Number: 1000113657-2018-00719
• Device Sequence Number: 1512689
• Product Code: NBW
• UDI-Device Identifier: 00050428264706
• UDI-Public: (01)00050428264706
• Combination Product (Y/N): N
• Initial Reporter State: CA
• PMA/510(K) Number: K032657
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 07/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: TRUETRACK
• Device Catalogue Number: A4H01-81
• Device Lot Number: RV5230
• 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: 06/08/2018
• Initial Report FDA Received Date: 07/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1