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	04/12/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Product not yet returned for evaluation.Customer returned replacement meter - unable to test.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.The customer is concerned with tests results from results obtained of 182mg/dl.The customer's expected fasting blood glucose test result range is 90 to 130mg/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.The product is stored according to specification in the living room.During the call on (b)(6) 2017, a back to back blood test was performed by the customer fasting and produced test results of 179 and 161mg/dl using true track meter.The test strip lot manufacturer's expiration date is 03/31/2019 and open vial date is (b)(6) 2017.The meter memory was reviewed for previous test result history: 181mg/dl (b)(6) 2017 08:39 am fasting: yes, 128mg/dl (b)(6) 2017 06:14 pm fasting: yes, 182mg/dl (b)(6) 2017 08:21 am fasting: yes, 254mg/dl (b)(6) 2017 02:13 pm fasting: no.Memory concerns: customer is concerned with 182mg/dl fasting result.
Additional Manufacturer Narrative
(b)(4).Returned meter evaluated with no defect found.Test strips not returned for evaluation.Most likely underlying root cause of malfunction: user had an inaccurate reference.Test strip udi# (b)(4).
Event or Problem Description
Consumer reported complaint for high blood glucose test results.The customer is concerned with tests results from results obtained of 182 mg/dl.The customer's expected fasting blood glucose test result range is 90 to 130 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.The product is stored according to specification in the living room.During the call on (b)(6) 2017, a back to back blood test was performed by the customer fasting and produced test results of 179 and 161 mg/dl using true track meter.The test strip lot manufacturer's expiration date is 03/31/2019 and open vial date is (b)(6) 2017.The meter memory was reviewed for previous test result history: (b)(6).Memory concerns: customer is concerned with 182 mg/dl fasting result.

• 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: 6549267
• Report Number: 1000113657-2017-00794
• Device Sequence Number: 865070
• Product Code: NBW
• UDI-Device Identifier: 00087701866807
• UDI-Public: (01)00087701866807
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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,Followup
• Report Date (Section B): 05/23/2017

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: RT5004
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2017
• Was the Report Sent to FDA?: No
• Event Location: Home
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 04/12/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/05/2017
• Supplement Report FDA Received Date: 05/23/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1