MAUDE Adverse Event Report: TRIVIDIA HEALTH, INC. TRUETRACK; BLOOD GLUCOSE SYSTEM

Model Number	TRUETRACK
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/14/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Returned meter evaluated with no defect found.Test strip vial returned expired (3/30/2017) - unable to test.Most likely underlying root cause: mlc-6- passed expiration date.(b)(4).
Event or Problem Description
Consumer reported complaint for reading of hi.The expected fasting blood glucose test result range is :120-126mg/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 storage location is undisclosed.The test strip lot manufacturer's expiration date is 03/30/2017 (expired) and open vial date is (b)(6) 2016 (more than 4 months).The meter memory was reviewed for previous test result history(date/time not set): hi (b)(6) 2017 12:01 pm fasting: no; 273mg/dl (b)(6) 2017 08:25 pm fasting: yes; 290mg/dl (b)(6) 2017 08:12 pm fasting: yes; 454mg/dl (b)(6) 2017 10:19 pm fasting: yes; 206mg/dl (b)(6) 2017 09:30 pm fasting: yes.Memory concerns: customer concerned with results (b)(6) 2017 of hi.The normal fasting glucose range is 120mg/dl to 126mg/dl over a year ago when he was checking regularly.The customer is using expired test strips and he has been using the same vial for a year.

• 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: 6690922
• Report Number: 1000113657-2017-01257
• Device Sequence Number: 1973267
• Product Code: NBW
• UDI-Device Identifier: 00052569132463
• UDI-Public: (01)00052569132463
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 07/06/2017

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: RR4531
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/26/2017
• Was the Report Sent to FDA?: No
• Event Location: Home
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/14/2017
• Initial Report FDA Received Date: 07/06/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1