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

Model Number	TRUBALANCE
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Codes	Headache (1880); Loss of consciousness (2418); Shaking/Tremors (2515)
Date of Event	10/12/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Customer will not return the complaint product; customer purchased another product at (b)(4).Most likely underlying root cause of malfunction:user had an inaccurate reference.Manufacturer contacted customer with follow up phone call on (b)(6) 2016, for knowing customer's conditions; customer's condition improved; customer reported had not any symptoms; customer reported is not longer using the true-balance; customer reported is testing with the (b)(4) purchased at (b)(4).
Event or Problem Description
Costumer reported complaint via email for high blood glucose test results.The customer is concerned with tests results from all of the results obtained.The customer's expected non-fasting blood glucose test result range is 70 to 90mg/dl.The customer did report symptoms of feeling lightheaded, shaky and loss of consciousness.Customer reported was at the hospital on (b)(6) 2016 as a result of the high blood glucose results and symptoms.The test strip lot manufacturer's expiration date is 01/29/2019 and open vial date is undisclosed.The meter memory was reviewed for previous test result history (date / time not set): customer states that ran a blood test and obtained the blood glucose result of 100mg/dl fasting customer tested at the hospital and obtained results of 30mg/dl not fasting.The customer treated with glucose fluids to raise the glucose level.Customer states was in the hospital for 3-4 hours; customer tested before discharged and obtained results of 85mg/dl as the same as with the true balance with result of 120mg/dl.Customer contacted (b)(4) and got a replacement with another true balance meter.Customer states that considered purchase another meter at (b)(4) , the (b)(4) all-in one.Customer run back to back testing on same hand different with the (b)(4) meter and the results were very close.Customer then run a blood test with the true balance meter and got 110mg/dl and then 12mg/dl same hand same finger.The meter was giving inaccurate results.Customer state that is hypoglycemia.Customer states that the normal glucose range is 70-90mg/dl not fasting.Customer states that he does not run fasting blood sugar.Customer tests 1 hour after meals.Customer ran the control solution test and it was within range but he is still not trusting the results.Customer is unable to find the meter that was using that was having the issues.(b)(4) send a new replacement meter and he states that it is doing the same thing.Customer only use it 3 times and did not think the results were accurate.Customer is comfortable using the (b)(4) meter instead since is accurate.Customer does not want to get the meter replace and would like to get a refund for the meter and strips.

• Brand Name: TRUBALANCE
• Common Device Name: BLOOD GLUCOSE SYSTEM
• Manufacturer (Section D): TRIVIDIA HEALTH, INC.; 2400 nw 55th court; fort lauderdale FL 33309
• MDR Report Key: 6118798
• Report Number: 1000113657-2016-01881
• Device Sequence Number: 19055977
• Product Code: NBW
• UDI-Device Identifier: 00021292007959
• UDI-Public: (01)00021292007959(17)190129(10)BT4956
• Combination Product (Y/N): N
• Initial Reporter State: FL
• PMA/510(K) Number: K090495
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 11/21/2016

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: TRUBALANCE
• Device Catalogue Number: H4H01-81
• Device Lot Number: BT4956
• 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: 10/26/2016
• Initial Report FDA Received Date: 11/21/2016
• 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
• Outcome Attributed to Adverse Event: Hospitalization