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	07/02/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Returned meter evaluated with no defect found.Test strips not returned for evaluation.Most likely underlying root cause: mlc-20-user's test strip had poor storage(kitchen).(b)(4).Manufacturer contacted customer (several attempts) in a follow-up call to ensure that the replacement products resolved the initial concern - 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 results.Wife is calling on behalf of the customer.The customer is concerned with results obtained of 227, 382, 300 and 489mg/dl.The expected fasting blood glucose test result range is 90 to 120mg/dl.The customer feels well and did not report symptoms.Medical attention is not reported as a result of the actual blood glucose results.The product is not stored by customer according to specification in the bathroom.Test strip lot manufacturer's expiration date is 07/23/2020 and open vial date is (b)(6) 2018.The meter memory was reviewed for previous test result history: (date/time not stored correctly) result 1:227mg/dl date: (b)(6) 2017 time:12:04a n/fasting; result 2:382mg/dl date: (b)(6) 2017 time:12:00a n/ fasting; result 3:300mg/dl date: (b)(6) 2017 time:7:05a n/fasting; result 4:489mg/dl date: (b)(6) 2017 time:6:18p n/fasting; result 5:166mg/dl date: (b)(6) 2017 time:6:41p n/fasting; strips were exposed to extreme heat for 3 hours on (b)(6) 2018.

• 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: 7715345
• Report Number: 1000113657-2018-00792
• Device Sequence Number: 19149796
• Product Code: NBW
• UDI-Device Identifier: 00011822577540
• UDI-Public: (01)00011822577540
• 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: other
• Initial Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 07/24/2018

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 Model Number: TRUETRACK
• Device Catalogue Number: A4H01-81
• Device Lot Number: RV5232
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/17/2018
• Was the Report Sent to FDA?: No
• Event Location: Home
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/02/2018
• Initial Report FDA Received Date: 07/24/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1