MAUDE Adverse Event Report: TRIVIDIA HEALTH, INC. TRUEMETRIX; BLOOD GLUCOSE SYSTEM

Model Number	TRUEMETRIX
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	Polydipsia (2604)
Date of Event	10/02/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Product not yet returned for evaluation.Most likely underlying root cause: (b)(4) - user has high glucose value test strip udi# (b)(4).Note: 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.Product letter was send to the customer to contact customer care.
Event or Problem Description
Consumer reported complaint for hi accompanied by symptoms.The expected fasting blood glucose test result range is 148-150mg/dl.The customer did report symptoms of thirst.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 fasting by the customer and produced test results of 230 and 236mg/dl using true metrixmeter.The test strip lot manufacturer's expiration date is 11/30/2018 and open vial date is (b)(6) 2017.The meter memory was reviewed for previous test result history.Result 1 : 236mg/dl date: (b)(6) 2017time: 13:03 fasting.Result 2 : 230 mg/dl date: (b)(6) 2017time: 15;25 05:58fasting.Result 3 : 280 mg/dl date: (b)(6) 2017time: 14:03 fasting.Result 4 : 336mg/dl date: (b)(6) 2017 time: 12:37 fasting.Result 5 : hi date: (b)(6) 2017 time: 09:51fasting.

• Brand Name: TRUEMETRIX
• Common Device Name: BLOOD GLUCOSE SYSTEM
• Manufacturer (Section D): TRIVIDIA HEALTH, INC.; 2400 nw 55th court; fort lauderdale FL 33309
• MDR Report Key: 6976462
• Report Number: 1000113657-2017-01861
• Device Sequence Number: 1156260
• Product Code: NBW
• UDI-Device Identifier: 00052569138526
• UDI-Public: (01)00052569138526
• Combination Product (Y/N): N
• Initial Reporter State: TX
• PMA/510(K) Number: K140100
• 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): 10/25/2017

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: TRUEMETRIX
• Device Catalogue Number: RE4H01-81
• Device Lot Number: MU2493
• 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: 10/02/2017
• Initial Report FDA Received Date: 10/25/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1