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	05/05/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Product not yet returned for evaluation.Most likely underlying root cause of malfunction: user's test strip had poor storage (kitchen).The test strips referenced in this report are part of recall #1052693-06/13/16-001-r.
Event or Problem Description
Consumer reported complaint for high blood glucose test results.Mother is calling on behalf of the customer.The customer is concerned with test results from results obtained of 440 mg/dl.The customer's expected fasting blood glucose test result range is 150 - 170 mg/dl.At the time of the call on (b)(6) 2017 the customer felt well and did not report any symptoms.Mother stated that she had called 9-1-1 due to result obtained on meter of 440 mg/dl (fasting).Mother stated that the customer was feeling fine but to be safe had called 9-1-1.Mother stated that customer had gone to the hospital on (b)(6) 2017; mother stated that they gave customer fluids and sent her home.Mother stated she could not remember what customer's blood sugar was at the hospital.During the call on (b)(6) 2017, 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 kitchen.The test strip lot manufacturer's expiration date is 10/13/2017 and open vial date is (b)(6) 2017.The meter memory was reviewed for previous test result history: (b)(6).Memory concerns:customer is concerned with 440 mg/dl fasting result.

• 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: 6601299
• Report Number: 1000113657-2017-00924
• Device Sequence Number: 1267142
• Product Code: NBW
• UDI-Device Identifier: 00021292007959
• UDI-Public: (01)00021292007959(17)171013(10)BS4651
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: Replace
• Type of Report: Initial
• Report Date (Section B): 05/31/2017

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 Expiration Date: 10/13/2017
• Device Model Number: TRUBALANCE
• Device Catalogue Number: H4H01-81
• Device Lot Number: BS4651
• 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: 05/05/2017
• Initial Report FDA Received Date: 05/31/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1