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 Code	Hyperglycemia (1905)
Date of Event	04/19/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(manufacturer narrative = t, corrected data = f) (b)(4).Returned meter and returned test strips evaluated with no defects found.Most likely underlying root cause of malfunction: strip issue.
Event or Problem Description
Consumer reported complaint for hi blood glucose test results.The customer is concerned with tests results from results obtained of "hi".The customer's expected fasting blood glucose test result range is 260 to 300 mg/dl.The customer feels well and did not report any symptoms.Customer call paramedics as a result of the actual blood glucose results on (b)(6) 2017.The product is stored according to specification.The test strip lot manufacturer's expiration date is 02/28/2019 and open vial date is (b)(6) 2017.The meter memory was reviewed for previous test result history (date / time not set): true metrix hi (b)(6) 2017 09:23:00 pm not fasting.True metrix hi (b)(6) 2017 07:47:00 pm not fasting.Memory concerns: customer is concerned with all of the readings customer called in concerning hi result.Customer states that she was recently hospitalized due to a heart attack and since has had high results.Customer states that on (b)(6) 2017, she took her blood glucose result and meter read hi.Customer says she called for a paramedic and when they tested her glucose levels on their equipment, meter read 439 mg/dl (non-fasting).Customer was treated with insulin.She did not go back to the hospital.

• 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: 6573493
• Report Number: 1000113657-2017-00861
• Device Sequence Number: 13475474
• Product Code: NBW
• UDI-Device Identifier: 00021292007959
• UDI-Public: (01)00021292007959(17)190228(10)BT4983
• Combination Product (Y/N): N
• Initial Reporter State: CA
• PMA/510(K) Number: K090495
• 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): 05/17/2017

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: TRUBALANCE
• Device Catalogue Number: H4H01-81
• Device Lot Number: BT4983
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/04/2017
• Was the Report Sent to FDA?: No
• Event Location: Home
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/19/2017
• Initial Report FDA Received Date: 05/17/2017
• 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