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

Model Number	TRUBALANCE
Medical Device Problem Code	Device Displays Incorrect Message (2591)
Health Effect - Clinical Codes	Fatigue (1849); Weakness (2145)
Date of Event	11/20/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(manufacturer narrative = t, corrected data = f) (b)(4).Product not returned for evaluation.Customer disconnected the call; unable to send replacement product and unable to make contact with her on follow-up attempts.Most likely underlying root cause: mlc-18- user has high glucose value.Test strip udi (b)(4).Note: unable to contact the customer via telephone at call backs on 11/21/2017, 11/22/2017 and 11/28/2017.Unable to send product notification to customer as no address on file.
Event or Problem Description
Consumer reported complaint for e-5 error: test strip error.Daughter is calling on behalf of the customer.The e-5 error occurred as soon as the blood sample was absorbed.The customer's expected blood glucose test result range was undisclosed.At the time of the call, the customer reported feeling weak and tired.The customer declined the need for medical attention at the time of the call.During the call on (b)(6) 2017, a blood test was not performed by the customer; the customer had disconnected the call.The product storage was undisclosed.The test strip lot manufacturer's expiration date is 12/29/2019 and open vial date was undisclosed.The meter memory was not reviewed for previous test result history.

• 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: 7114082
• Report Number: 1000113657-2017-02063
• Device Sequence Number: 11128082
• 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: other
• Initial Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 12/13/2017

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 Expiration Date: 12/29/2019
• Device Model Number: TRUBALANCE
• Device Catalogue Number: H4H01-81
• Device Lot Number: BU5123
• 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: 11/20/2017
• Initial Report FDA Received Date: 12/13/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1