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 Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/24/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Product not yet returned for evaluation.Most likely underlying root cause of malfunction: user had an inaccurate reference.(b)(4).
Event or Problem Description
Consumer reported complaint for high blood glucose test results.Caregiver is calling on behalf of the customer.The customer is concerned with test results from results obtained of 454, 410 and 207 mg/dl.The customer's expected fasting blood glucose test result range is 113 - 150 mg/dl.The customer feels well and did not report any symptoms.Medical attention is not reported as a result of the actual blood glucose results.During the call on (b)(6) 2017, a back to back blood test was performed by the customer non-fasting and produced test results of 535 mg/dl using truetrack meter and 455 mg/dl using truetrack meter.The product is stored according to specification.The test strip lot manufacturer's expiration date is 02/21/2018 and open vial date is 04/19/2017.The meter memory was reviewed for previous test result history: 454mg/dl (b)(6) 2017 08:00 am fasting:yes; 410mg/dl (b)(6) 2017 07:00 pm fasting:yes 207mg/dl (b)(6) 2017 08:00 am fasting:yes; 292mg/dl (b)(6) 2017 08:00 pm fasting:yes; 223mg/dl (b)(6) 2017 08:00 am fasting:yes.Memory concerns:customers caregiver is concerned with the results of 454, 410, 207, 292 and 223 mg/dl from the meters memory.

• 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: 6572389
• Report Number: 1000113657-2017-00853
• Device Sequence Number: 13669817
• Product Code: NBW
• UDI-Device Identifier: 00096295111866
• UDI-Public: (01)00096295111866
• Combination Product (Y/N): N
• Initial Reporter State: OR
• PMA/510(K) Number: K032657
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 05/17/2017

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 Expiration Date: 02/21/2018
• Device Model Number: TRUETRACK
• Device Catalogue Number: A4H01-81
• Device Lot Number: RU4759
• 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: 04/24/2017
• Initial Report FDA Received Date: 05/17/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SECOND THERAPY