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	10/25/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Product not yet returned for evaluation.Most likely underlying root cause: (b)(4) user had an inaccurate reference: alternate meter: the end user is comparing results obtained from one of trividia's bgm system to the results from another trividia's bgm system.Test strip udi# (b)(4).
Event or Problem Description
Consumer reported complaint for high blood glucose test results.The customer is concerned with test results from meter to meter comparison of 205 mg/dl fasting using truetrack meter and 112 mg/dl fasting using trueresult meter.The customer is also concerned that results obtained of 205, 315 and 195 mg/dl are too high.The customer's expected fasting blood glucose test result range is 95 - 140 mg/dl.Customer was advised to discontinue use of trueresult and upgrade was sent, reference internal report (b)(4).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 not performed by the customer.The product is stored according to specification in a cabinet in the living room.The test strip lot manufacturer's expiration date is 04/26/2018 and open vial date at time of call is one week.The meter memory was reviewed for previous test result history: result1: 205mg/dl date: (b)(6) 2017 time:9:52am fasting.Result2: 137mg/dl date: (b)(6) 2017 time:7:22am fasting.Result3 : 129mg/dl date: (b)(6) 2017 time:7:19am fasting.Result4 : 315mg/dl date: (b)(6) 2017 time:8:55pm fasting.Result5: 195mg/dl date: (b)(6) 2017 time:6:42am fasting.Customer is concerned with back to back fasting results done with meter to meter comparison.

• 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: 7045002
• Report Number: 1000113657-2017-01964
• Device Sequence Number: 1357854
• Product Code: NBW
• UDI-Device Identifier: 00011822577540
• UDI-Public: (01)00011822577540
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 11/20/2017

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: 04/26/2018
• Device Model Number: TRUETRACK
• Device Catalogue Number: A4H01-81
• Device Lot Number: RS4810
• 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: 10/25/2017
• Initial Report FDA Received Date: 11/20/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1