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); Confusion/ Disorientation (2553)
Date of Event	01/06/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Product not yet returned for evaluation.Most likely underlying root cause of malfunction: user did not insert code ship.(b)(4).
Event or Problem Description
Consumer reported complaint for code chip error accompanied by symptoms.The customer is concerned with error and symptoms.The customer's expected fasting blood glucose test result range is undisclosed.The customer reports symptoms of feeling tired, confused and having a headache.Medical attention is not reported as a result of the actual blood glucose results and reported symptoms.The product storage location is undisclosed.The test strip lot manufacturer's expiration date is 03/14/2019 and open vial date is undisclosed.The meter memory was not reviewed for previous test result history.Customer is having a headache, feels tired and confusion.On the first follow up customer advised that her conditions have not improved and that she did not seek medical attention.On the second follow up customer questioned why we keep calling.We explained to the customer that we were concerned with how she is feeling.Customer then states that she has to go and then disconnected the phone.

• 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: 6292633
• Report Number: 1000113657-2017-00166
• Device Sequence Number: 13464808
• Product Code: NBW
• UDI-Device Identifier: 00010939755339
• UDI-Public: (01)00010939755339
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 02/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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: RT4988
• 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: 01/06/2017
• Initial Report FDA Received Date: 02/01/2017
• 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