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	Blurred Vision (2137); Urinary Frequency / Polyuria (2275); Polydipsia (2604)
Date of Event	05/21/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Returned meter evaluated with no defect found.Test strips not returned for evaluation.Most likely underlying root cause: mlc-20-user's test strip had poor storage(bathroom).(b)(4).Manufacturer contacted customer on a follow-up call to ensure the customer's condition since the initial call; customer's condition improved, and no longer experiencing symptoms.Customer spoke to physician via phone on (b)(6) 2018 and physician requested customer to go to quest to obtain glucose blood lab work on (b)(6) 2018.No hospitalization or medical attention reported.Customer was also informed by physician to eliminated sugar, carbs from diet and also to increase legumes and increase water intake.Results for blood lab work will be received on (b)(6) 2018.Customer satisfied with the replacement product.
Event or Problem Description
Consumer reported complaint for high blood glucose results.The customer is concerned with all the results obtained.The expected fasting blood glucose test result range is 95-190 mg/dl.The customer did report symptoms of blurry vision, increase urination and increase thirst, increased hunger.Medical attention is not reported as a result of the actual blood glucose results and reported symptoms.The product is stored by customer according to specification in the bathroom.The test strip lot manufacturer's expiration date is 01/19/2019 and open vial date is unknown.The meter memory was reviewed for previous test result history: (date/time not stored correctly) (b)(6).

• 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: 7582787
• Report Number: 1000113657-2018-00630
• Device Sequence Number: 19335770
• Product Code: NBW
• UDI-Device Identifier: 00096295129489
• UDI-Public: (01)00096295129489
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Replace
• Type of Report: Initial
• Report Date (Section B): 06/08/2018

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: RT4948
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/31/2018
• Was the Report Sent to FDA?: No
• Event Location: Home
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/21/2018
• Initial Report FDA Received Date: 06/08/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1