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	11/30/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Product not returned for evaluation.Customer declined replacement product at this time.Most likely underlying root cause: mlc-62-user had poor technique test strip udi# (b)(4).Note: manufacturer contacted customer (several attempts) in a follow-up call to ensure that the initial concern was resolved - unable to establish contact with the customer at this time.
Event or Problem Description
Consumer reported complaint for high blood glucose test results.The customer is concerned with tests results of 305 and 319 mg/dl.The customer's expected fasting blood glucose test result range is 150 - 175 mg/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.During the call on (b)(6) 2018, a back-to-back blood test was performed by the customer non-fasting and produced test results of 240 mg/dl and 243 mg/dl using truetrack meter.The product is stored according to specification in the bedroom.The test strip lot manufacturer's expiration date is 09/15/2020, and open vial date is (b)(6) 2018.The meter memory was reviewed for previous test result history: (b)(6) customer states the meter is reading high blood results and only concerned with this.Customer states their normal fasting range is 150mg/dl-175mg/dl fasting.Customer adjusted meter's position from horizontal position while testing to a vertical position.Customer states they adjusted their testing technique by rubbing hands below waist level prior to pricking finger.Customer denies the need for medical attention at the time of call and denies signs and symptoms of hypoglycemia or hyperglycemia.Customer declined replacements and will implement new testing techniques and i will follow back-up with customer.

• 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: 8184731
• Report Number: 1000113657-2018-01272
• Device Sequence Number: 2879388
• Product Code: NBW
• UDI-Device Identifier: 00021292001018
• UDI-Public: (01)00021292001018
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 12/20/2018

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 Expiration Date: 09/15/2020
• Device Model Number: TRUETRACK
• Device Catalogue Number: A4H01-81
• Device Lot Number: RV5257
• 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: 11/30/2018
• Initial Report FDA Received Date: 12/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1