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	Confusion/ Disorientation (2553)
Date of Event	02/13/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(manufacturer narrative = t, corrected data = f) (b)(4).Product not yet returned for evaluation.Most likely underlying root cause: mlc-18- user has high glucose value.Test strip (b)(4) note: per follow up call on 02/20/2018: (as per customer himself) customer was hospitalized on "(b)(6) 2018".He was diagnosed with hyperglycemia and was treated with iv fluids.He was discharged on (b)(6) 2018.Customer is no longer experiencing symptoms and no further medical attention was required.
Event or Problem Description
Consumer reported complaint for high blood glucose results accompanied by symptoms.Nurse is calling on behalf of the customer.The customer is concerned with all of the results obtained.The expected fasting blood glucose test result range is 85-188 mg/dl and 117-250 mg/dl non- fasting.The customer did report symptoms of altered mental status, confusion.Medical attention is reported as a result of the actual blood glucose results and reported symptoms.The product is not stored by customer according to specification in the kitchen.The test strip lot manufacturer's expiration date is 11/13/2018 and open vial date is unknown.The meter memory was reviewed for previous test result history: (date/time not stored correctly) (b)(6).Nurse states that today (b)(6) 2018 she checked the customer's blood sugar and the results were 460 mg/dl non-fasting.Customer was confused and did not recognized his surroundings.Nurse contacted the customer's son who advised nurse to take patients to the hospital.Customer arrived to the hospital 45 minutes later and his blood sugar was 230 mg/dl non- fasting with their meter.Nurse sates that she did not administer any medication prior to going to the hospital.Customer is currently at the hospital with the diagnosis of altered mental status.

• 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: 7325168
• Report Number: 1000113657-2018-00287
• Device Sequence Number: 19233830
• Product Code: NBW
• UDI-Device Identifier: 00021292003135
• UDI-Public: (01)00021292003135
• Combination Product (Y/N): N
• Initial Reporter State: ME
• 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): 03/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Model Number: TRUBALANCE
• Device Catalogue Number: H4H01-81
• Device Lot Number: BT4914
• 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: 02/13/2018
• Initial Report FDA Received Date: 03/08/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization