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	07/18/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(manufacturer narrative = t, corrected data = f) (b)(4).Product not returned for evaluation.Customer declined replacement product at this time.Most likely underlying root cause : mlc-62 - user had poor technique.Test strip (b)(4).Note: customer is not using correct technique.Customer did mention not washing hands before testing.
Event or Problem Description
Consumer reported complaint for high and erratic blood glucose test results.Customer tested back to back because first result was higher than expected.The customer is concerned with tests results from back to back blood tests of 161 and 107 mg/dl.The customer's expected fasting blood glucose test result range is 90 - 105 mg/dl.Customer is not using correct technique.Customer did mention not washing hands before testing.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 86 mg/dl and 89 mg/dl using truetrack meter.The product is stored according to specification.The test strip lot manufacturer's expiration date is 06/30/2019 and open vial date is (b)(6) 2017.The meter memory was reviewed for previous test result history: (b)(6).Customer called concerned of erratic results.Customer tested back to back because first result was higher than expected.Customer received results with a 54 point variance.Customer performed back to back blood test and says he will keep meter and call back if there are any other concerns.

• 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: 6784361
• Report Number: 1000113657-2017-01535
• Device Sequence Number: 1412772
• Product Code: NBW
• UDI-Device Identifier: 00011822577540
• UDI-Public: (01)00011822577540
• Combination Product (Y/N): N
• 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): 08/10/2017

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: 06/30/2019
• Device Model Number: TRUETRACK
• Device Catalogue Number: A4H01-81
• Device Lot Number: RU5068
• 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: 07/18/2017
• Initial Report FDA Received Date: 08/10/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1