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

Model Number	TRUEBALANCE
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/26/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Note: manufacturer contacted customer (several attempts) in a follow-up call to ensure that the initial concern is resolved - unable to establish contact at this time.No product notification letter sent since no customer address on file.
Event or Problem Description
Consumer reported complaint for high blood glucose test results.The customer is concerned with tests results from results obtained of 200 and 300 mg/dl fasting.The customer's expected fasting blood glucose test result range is 125 - 130 mg/dl.The customer feels well and did not report any symptoms.Medical attention is not reported as a result of the actual blood glucose results.The product is not stored according to specification and is stored in the kitchen.The test strip lot manufacturer's expiration date is 03/18/2021 and test strips were opened one week ago.During the troubleshooting process, the call was disconnected; attempted to call customer back but was unable to reach.During the call a back to back blood test was not performed by the customer.The meter memory was not reviewed for previous test result history.

• Brand Name: TRUEBALANCE
• Common Device Name: BLOOD GLUCOSE SYSTEM
• Manufacturer (Section D): TRIVIDIA HEALTH, INC.; 2400 nw 55th court; fort lauderdale FL 33309
• MDR Report Key: 8625486
• Report Number: 1000113657-2019-00538
• Device Sequence Number: 19318155
• Product Code: NBW
• UDI-Device Identifier: 00021292003135
• UDI-Public: (01)00021292003135
• Combination Product (Y/N): N
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 05/20/2019

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: 03/18/2021
• Device Model Number: TRUEBALANCE
• Device Catalogue Number: H4H01-81
• Device Lot Number: BV5304
• 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: 04/26/2019
• Initial Report FDA Received Date: 05/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1