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	11/30/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal report # (b)(4).Product not yet 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 customer is concerned with results obtained above 200mg/dl.The expected fasting blood glucose test result range is 140mg/dl.The customer feels well and 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 in the dining room.During the call on (b)(6) 2017, a blood test was performed fasting by the customer and produced test results of 195mg/dl using true track meter.The test strip lot manufacturer's expiration date is 12/21/2019 and open vial date is 11/30/2017.The meter memory was reviewed for previous test result history: (b)(6).Customer called in states the meter is reading high.Customer states the meter read 300mg/dl.Customer states his normal fasting range is 140mg/dl fasting.His last a1c was 3 or 4 month was 8.1% customer denies the need for medical attention at the time of call and denies signs and symptoms of hyperglycemia at the time of call.Customer was advised him of the a1c (186mg/dl) and he said that he blood sugar has never been higher than 140mg/dl up until recently.Customer states that he has not had any changes in diet/meal/exercise.Customer was educated on his a1c and still wanted the product replaced.

• 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: 7138734
• Report Number: 1000113657-2017-02098
• Device Sequence Number: 16369442
• Product Code: NBW
• UDI-Device Identifier: 00021292004576
• UDI-Public: (01)00021292004576
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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): 12/21/2017

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: RU5118
• 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: 11/30/2017
• Initial Report FDA Received Date: 12/21/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1