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	08/02/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal report # (b)(4).Returned meter evaluated with no defect found.Test strips not returned for evaluation.Most likely underlying root cause: mlc-58-user had an inaccurate reference: self: the person is using themselves as the reference or how they feel at the time they run the blood test.Test strip udi#: (b)(4).
Event or Problem Description
Consumer reported complaint for high blood glucose results.The expected fasting blood glucose test result range is 90 to 120mg/dl.The customer did not report symptoms.Medical attention is not reported as a result of the actual blood glucose results.The product is stored by customer according to specification.During the call on (b)(6) 2017, a back to back blood test was performed fasting by the customer and produced test results of 147 and 145mg/dl using true track meter.The test strip lot manufacturer's expiration date is 02/21/2018 and open vial date is (b)(6) 2017.The meter memory was reviewed for previous test result history.The 164mg/dl (b)(6) 2017 01:26 pm fasting: yes, 134mg/dl (b)(6) 2017 02:27 am fasting: yes, 146mg/dl (b)(6) 2017 10:59 am fasting: yes, 143mg/dl (b)(6) 2017 10:13 am fasting: yes, 149mg/dl (b)(6) 2017 09:45 pm fasting: yes.

• 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: 6810397
• Report Number: 1000113657-2017-01598
• Device Sequence Number: 19349308
• Product Code: NBW
• UDI-Device Identifier: 00096295111866
• UDI-Public: (01)00096295111866
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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): 08/22/2017

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 Model Number: TRUETRACK
• Device Catalogue Number: A4H01-81
• Device Lot Number: RU4759
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/09/2017
• Was the Report Sent to FDA?: No
• Event Location: Home
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/02/2017
• Initial Report FDA Received Date: 08/22/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1