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

Model Number	TRUBALANCE
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/30/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(manufacturer narrative = t, corrected data = f) internal report # (b)(4).Returned meter evaluated with no defect found.Test strips not returned for evaluation.Most likely underlying root cause of malfunction: user's test strip had poor storage (kitchen).
Event or Problem Description
Consumer reported complaint for low blood glucose test results.The customer is concerned with tests results from results obtained of 48 mg/dl.The customer's expected fasting blood glucose test result range is 85 - 92 mg/dl.At the time of call on (b)(6) 2017 , the customer felt well and did not report any symptoms.The customer stated she did not feel any hypoglycemic symptoms at the time of receiving low result of 48 mg/dl (fasting) on (b)(6) 2017.Medical attention is not reported as a result of the actual blood glucose results.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 09/30/2018 and open vial date at time of call is three weeks.Customer stated she has not had any recent changes in diet, exercise, or medications.Customer stated she takes glipizide and actos for diabetes management.The meter memory was reviewed for previous test result history (date/time not set): 87mg/dl (b)(6) 2017 10:39 pm fasting:yes; 85mg/dl (b)(6) 2017 07:07 am fasting:yes; 70mg/dl (b)(6) 2017 07:57 am fasting:yes; 72mg/dl (b)(6) 2017 10:25 pm fasting:yes; 48mg/dl (b)(6) 2017 06:07 am fasting:yes; memory concerns:48mg/dl.

• 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: 6349274
• Report Number: 1000113657-2017-00362
• Device Sequence Number: 663625
• Product Code: NBW
• UDI-Device Identifier: 00021292007942
• UDI-Public: (01)00021292007942(17)180930(10)BT4902
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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): 02/22/2017

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: 09/30/2018
• Device Model Number: TRUBALANCE
• Device Catalogue Number: H4H01-81
• Device Lot Number: BT4902
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2017
• Was the Report Sent to FDA?: No
• Event Location: Home
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/30/2017
• Initial Report FDA Received Date: 02/22/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SECOND THERAPY