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 Information (3190)
Date of Event	03/30/2018
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-58-user had an inaccurate reference: self: the person is using themselves as the reference or how they feel at the time they run the blood test.(b)(4).Manufacturer contacted customer (several attempts) in a follow-up calls - unable to establish contact with the customer at this time.Product notification letter sent to customer to contact customer care.
Event or Problem Description
Consumer reported complaint for high blood glucose test results.The customer is concerned with tests results from results obtained of 393 mg/dl non-fasting.The customer's expected fasting blood glucose test result range is 100 - 110 mg/dl; a non-fasting expected test result range was not provided.At the time of the call, the customer felt well and did not report any symptoms.Customer stated that a few days ago she had not been feeling well, customer did not say what the symptoms were.Customer had called her doctor and went to have her blood tested.Customer's blood test result while at the doctor's office was 240 mg/dl fasting.Customer did not disclose if any treatment was received.Customer left the doctor's office the same day, no new medications or healthcare program was suggested.During the call on (b)(6) 2018, a back to back blood test was not performed by the customer.The product is not stored according to specification; customer keeps in her purse.The test strip lot manufacturer's expiration date is 05/31/2019 and open vial date is one month.Customer was not able to go through the meter memory.Result 1:108mg/dl (b)(6) 2:20pm 2 or more hours after eating; result 2:393mg/dl not date given but 1 hr after eating; result 3:101mg/d not time or date given.

• 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: 7456498
• Report Number: 1000113657-2018-00475
• Device Sequence Number: 19072411
• Product Code: NBW
• UDI-Device Identifier: 00011822577540
• UDI-Public: (01)00011822577540
• 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: consumer
• Initial Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 04/24/2018

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: 05/31/2019
• Device Model Number: TRUETRACK
• Device Catalogue Number: A4H01-81
• Device Lot Number: RT5054
• 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: 03/30/2018
• Initial Report FDA Received Date: 04/24/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1