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); Sweating (2444)
Date of Event	12/11/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Product not returned for evaluation.Customer declined replacement product at this time.Product is working as designed.Most likely underlying root cause: (b)(4)- user has high glucose value.Test strip udi# (b)(4).Note: manufacturer contacted customer on (b)(4) 2017 in a follow-up call in order to ensure the customer's condition since the initial call; customer's condition had improved and she did not currently have any diabetic symptoms.The customer did not have any medical intervention since the last call.The customer is continuing to use the truebalance meter and declined a replacement.
Event or Problem Description
Consumer reported complaint for hi blood glucose test results.The customer is concerned with test results from results obtained of hi.The customer's expected blood glucose test result range was undisclosed.Customer stated that she gets extremely high and low results, she is not concerned and that her doctor is aware of the high results she has been getting.The customer reported having a headache and sweating at the time of the call.During the call on (b)(6) 2017, a back to back blood test was not performed by the customer.The product is stored according to specification in the bedroom.The test strip lot manufacturer's expiration date is 01/31/2020 and open vial date is (b)(6) 2017.The meter memory was not reviewed for previous test result history (customer did not want to provide any further information about her meter).Calling customer back from a voicemail that was left.Customer states that she wants to know what hi means on the meter.I review with customer what hi means.Customer states that she gets extremely high and lows results and she is not concerned.Customer states that the her doctor is aware of the high results she have been getting.Customer is not concern with the meter, she knows that her glucose is high.Customer states that there is nothing wrong with the meter she just wants to know how high the meter reads.Customer does not want the meter to replace.Customer did not want to provide any further information about her meter.

• 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: 7168751
• Report Number: 1000113657-2018-00026
• Device Sequence Number: 13796044
• 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): 01/05/2018

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: 01/31/2020
• Device Model Number: TRUBALANCE
• Device Catalogue Number: H4H01-81
• Device Lot Number: BU5145
• 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: 12/11/2017
• Initial Report FDA Received Date: 01/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1