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	Headache (1880)
Date of Event	11/30/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Returned meter and returned test strips evaluated with no defects found.Most likely underlying root cause: mlc-18- user has high glucose value.(b)(4).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 hi reading accompanied by symptoms.The expected fasting blood glucose test result range is undisclosed.The customer did report symptoms of feeling head pressure.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 back to back blood test was performed non-fasting by the customer and produced test results of 494 and 420mg/dl using true track meter.The test strip lot manufacturer's expiration date is 06/21/2019 and open vial date is 2 weeks ago.The meter memory was reviewed for previous test result history: (date/time not stored correctly) result 1 :102mg/dl date:(b)(6) 2017 time:08:33pm fasting, result 2 :hi date: (b)(6) 2017 time:08:14am fasting, result 3 :479mg/dl date:(b)(6) 2017 time:12:01pm fasting, result 4 :hi date:(b)(6) 2017 time:10:10pm fasting, result 5 :hi date:(b)(6) 2017 time:10:08pm fasting.Customer is unsure of range.She states her sugar is as high as 400mg/dl fasting.Customer called in states the meter is reading hi.She is unsure what her a1c.Customer denies the need for medical attention at the time of call.

• 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: 7138259
• Report Number: 1000113657-2017-02094
• Device Sequence Number: 13678673
• Product Code: NBW
• UDI-Device Identifier: 00010939755339
• UDI-Public: (01)00010939755339
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 12/21/2017

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: RU5065
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2017
• Was the Report Sent to FDA?: No
• Event Location: Home
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/30/2017
• Initial Report FDA Received Date: 12/21/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1