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	11/20/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Product will not return; customer retained the product since customer is satisfied with meter readings.Most likely underlying root cause of malfunction: user had inaccurate reference.Test strip-udi#: (b)(4).Manufacturer contacted customer with followup phone calls even though during the initial phone caller stated feeling good but will seek medical attention; customer reported on (b)(6) 2016 was hospitalized for an asthma attack and high blood sugar.Customer was treated with levemir; customer unknown the blood glucose test results obtained when arrived; customer discharged on (b)(6) 2016 with blood glucose stabilized on 72mg/dl fasting; customer expressed been satisfied with the meter as he knows that the meter was reading properly.
Event or Problem Description
Costumer reported complaint for high blood glucose test results.(b)(6) staff, is calling on behalf of the customer.The customer is concerned with tests results from results obtained of 549mg/dl.The customer's expected fasting blood glucose test result range is 80 to 120mg/dl.The customer feels well and did not report any symptoms.Medical attention is reported as a result of the actual blood glucose results.The test strip lot manufacturer's expiration date is 12/31/2018 and open vial date is (b)(6) 2016.The meter memory was reviewed for previous test result history: a 549mg/dl, (b)(6) 2016 05:19 pm.Fasting: no.Undisclosed.Customer informed caller he was obtaining high readings from meter that he was concerned about as he was not experiencing any symptoms at time.Customer received the meter today (b)(6) 2016 from (b)(6) pharmacy and tested while at pharmacy, customer obtained a reading of 549mg/dl non-fasting (customer had a cup of tea within the last 2 hours).Customer is concerned with readings as he has never had such high readings.Asked caller to ask customer if he was experiencing any symptoms of high blood sugar,caller states customer denies having any symptoms but caller states customer is going to seek medical attention.

• 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: 6174245
• Report Number: 1000113657-2016-02027
• Device Sequence Number: 368518
• Product Code: NBW
• UDI-Device Identifier: 00050428318010
• UDI-Public: (01)00050428318010
• Combination Product (Y/N): N
• PMA/510(K) Number: K032657
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 12/14/2016

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: RT4942
• 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: 11/20/2016
• Initial Report FDA Received Date: 12/14/2016
• 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