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

Model Number	TRUBALANCE
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Urinary Frequency / Polyuria (2275)
Date of Event	12/19/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Product not returned for evaluation.No replacement product needed at this time.Complaint resolved by training during the time of the call.Product is working as designed.Most likely underlying root cause: mlc-101- user used the wrong strip test strip udi# (b)(4).Note: manufacturer contacted customer on (b)(6) 2018, in a follow-up call to ensure the customer's condition since the initial call; customer's condition had improved and he did not currently have any diabetic symptoms.Due to symptom of increased urination reported during initial call, customer had gone to their primary care physician on (b)(6)2018.Primary care physician had provided customer with medication, the same as the one he was using.Customer purchased the correct test strips for use with the truebalance meter and stated the meter is working as intended.
Event or Problem Description
Consumer reported complaint for test strip no recognizing or test strip not absorbing the blood.Wife is calling on behalf of the customer.The customer was using the incorrect test strips - lot mv2866 is a truemetrix test strip lot number and not for use with truebalance meter.Customer was advised to purchase the correct product.At the time of the call, the customer reported feeling physically ill with increased urination.Medical attention was not needed at the time of the call.

• 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: 8248589
• Report Number: 1000113657-2019-00033
• Device Sequence Number: 1439278
• 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): 01/15/2019

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: 10/24/2019
• Device Model Number: TRUBALANCE
• Device Catalogue Number: H4H01-81
• Device Lot Number: MV2866
• 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: 12/19/2018
• Initial Report FDA Received Date: 01/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1