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

Model Number	TRUETRACK
Medical Device Problem Code	Device Displays Incorrect Message (2591)
Health Effect - Clinical Codes	Headache (1880); Polydipsia (2604)
Date of Event	06/05/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Product not yet returned for evaluation.Most likely underlying root cause of malfunction: (b)(4)- insufficient blood sample applied to strip (user).Test strip udi# (b)(4).Note: manufacturer contacted customer (several attempts) in a follow-up call in order to ensure the customer's condition since the initial call - unable to establish contact with the customer at this time.
Event or Problem Description
Consumer reported complaint for e-2 error accompanied by symptoms.The expected fasting blood glucose test result range is 100 to 135mg/dl.The customer feels did report symptoms of dry mouth and headache.Medical attention is not reported as a result of the actual blood glucose results and reported symptoms.The product is stored by customer according to specification in the living room.During the call on (b)(6)2017, a blood test was performed by the customer and produced test results of e-2 using true track meter.The test strip lot manufacturer's expiration date is 03/15/2019 and open vial date is (b)(6)2017.The meter memory was not reviewed for previous test result history.

• 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: 6672195
• Report Number: 1000113657-2017-01105
• Device Sequence Number: 16584489
• Product Code: NBW
• UDI-Device Identifier: 00041220842438
• UDI-Public: (01)00041220842438
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 06/27/2017

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: RT4989
• 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: 06/05/2017
• Initial Report FDA Received Date: 06/27/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1