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	05/04/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Returned meter evaluated with no defect found.Wrong test strip vial returned - unable to test.Most likely underlying root cause of malfunction: user had an inaccurate reference.Competitor's meter: the end user is comparing results obtained from trividia's bgm system to the results from a competitor's bgm system.(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 110 to 115mg/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 non-fasting and produced test results of 225 and 232mg/dl using true track meter.The test strip lot manufacturer's expiration date is 02/21/2018 and open vial date is approximately two months ago.The meter memory was reviewed for previous test result history (date / time not set): (b)(6).Customer called concerning high results.Customer says that all of his results are higher than expected range.Also, customer states that recently, customer not sure exactly of which date, he went into the emergency room for a reason not related to diabetes.Customer said that he brought his meter along with him and had a nurse check his glucose levels with hospital meter and then with true track meter.Customer says he does not remember exact results but there was a variance of about 115 points (true track read higher).Customer did mention using alcohol pads to wipe finger off before getting blood.

• 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: 6589167
• Report Number: 1000113657-2017-00897
• Device Sequence Number: 13645026
• Product Code: NBW
• UDI-Device Identifier: 00021292001971
• UDI-Public: (01)00021292001971
• 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
• Report Date (Section B): 05/24/2017

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: RU4759
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/12/2017
• Was the Report Sent to FDA?: No
• Event Location: Home
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/04/2017
• Initial Report FDA Received Date: 05/24/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1