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	03/09/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Returned meter evaluated with no defect found.Returned test strips evaluated with defect found.Qc investigation on 3/27/2017 returned test strips produce low readings.Most likely underlying root cause of low readings: strips left outside of vial for an extended period of time (b)(4).
Event or Problem Description
Consumer reported complaint for high blood glucose test results.The customer is concerned with tests results from all of the results obtained.The customer's expected fasting blood glucose test result range is 90 to 120mg/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.During the call on (b)(6) 2017, a back to back blood test was performed by the customer fasting and produced test results of 175 and 174mg/dl using true track meter.The test strip lot manufacturer's expiration date is 03/22/2019 and open vial date is (b)(6) 2017.The meter memory was reviewed for previous test result history: (b)(6).The customer is calling in regards to getting high results when she tests on the meter.The customer is not having any symptoms of high blood sugar at this time.She takes her blood test fasting.She has not had any changes in diet or exercise.Customer states her blood sugar in the past few months have been going up and down and when she uses the true track meter on (b)(6) 2017 her blood sugar is high.The strips she was using on the 6th ((b)(4)) are completed and the customer open a new vial of strips and is still getting high results.

• 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: 6461094
• Report Number: 1000113657-2017-00607
• Device Sequence Number: 476436
• Product Code: NBW
• UDI-Device Identifier: 00021292001971
• UDI-Public: (01)00021292001971
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 04/05/2017

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: RT4995
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2017
• Was the Report Sent to FDA?: No
• Event Location: Home
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/09/2017
• Initial Report FDA Received Date: 04/05/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SECOND THERAPY