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	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/14/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Returned meter evaluated with no defect found.Returned test strips evaluated with defect found.Qc investigation on (b)(6) 2018 returned test strips produce high readings.Most likely underlying root cause of high results are due to improper storage: vial left open for an extended period of time.(b)(4).Manufacturer contacted customer on (b)(6) 2018 in a follow-up call to ensure that the replacement products resolved the initial concern; customer stated that the replacement product is working to their satisfaction and they have not had any medical intervention or symptoms since the last call.
Event or Problem Description
Consumer reported complaint for high blood glucose test results.The customer is concerned with tests results from results obtained of 172, 175, 183, 178, 164 mg/dl.Customer's expected fasting blood glucose test result range is 90 - 140 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.During the call on (b)(6) 2018, a back to back blood test was not performed by the customer.The product is not stored according to specification and is stored in the bathroom.The test strip lot manufacturer's expiration date is 04/30/2020 and open vial date is (b)(6) 2018.The meter memory was reviewed for previous test result history: result 1 :172mg/dl date: (b)(6) 2018 time:08:52am fasting ; result 2 :175mg/dl date: (b)(6) 2018 time:08:15 am fasting ; result 3 :183mg/dl date: (b)(6) 2018 time:08:12am fasting; result 4 :178mg/dl date: (b)(6) 2018 time:10:28am fasting; result 5 :164mg/dl date: (b)(6) 2018 time:08:20am fasting.

• 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: 7953280
• Report Number: 1000113657-2018-01018
• Device Sequence Number: 19198730
• Product Code: NBW
• UDI-Device Identifier: 00021292003135
• UDI-Public: (01)00021292003135
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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): 10/10/2018

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: 04/30/2020
• Device Model Number: TRUBALANCE
• Device Catalogue Number: H4H01-81
• Device Lot Number: BU5193
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/25/2018
• Was the Report Sent to FDA?: No
• Event Location: Home
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/14/2018
• Initial Report FDA Received Date: 10/10/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1