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

Model Number	TRUEMETRIX
Medical Device Problem Codes	High Test Results (2457); Device Displays Incorrect Message (2591)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/24/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Product not yet returned for evaluation.Customer obtained another meter at the pharmacy.Left old replacement at the pharmacy.Most likely underlying root cause: mlc-20-user's test strip had poor storage (kitchen).(b)(4).
Event or Problem Description
Consumer initially reported complaint for e-3 error; used test strip, test strip outside of vial too long, sample on top of test strip.The e-3 error occurred as soon as the test strip was inserted.Customer called in with wife's assistance.Customer also reported complaint for high results.The customer is concerned with test results from results obtained of 333mg/dl.The customer's expected fasting blood glucose test result range is 126 - 145 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)(4) 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 11/16/2018 and open vial date is 08/24/2017.The meter memory was reviewed for previous test result history (customer had only obtained one result): 333mg/dl, (b)(6) 2017, 12:27 pm ,fasting: yes.Memory concerns: 333mg/dl.Customer called in with his wife's assistance and states that his meter is reading high for him.Wife states customer is not diabetic just monitoring.

• Brand Name: TRUEMETRIX
• Common Device Name: BLOOD GLUCOSE SYSTEM
• Manufacturer (Section D): TRIVIDIA HEALTH, INC.; 2400 nw 55th court; fort lauderdale FL 33309
• MDR Report Key: 6875984
• Report Number: 1000113657-2017-01714
• Device Sequence Number: 19145165
• Product Code: NBW
• UDI-Device Identifier: 00052569138526
• UDI-Public: (01)00052569138526
• Combination Product (Y/N): N
• Initial Reporter State: TX
• PMA/510(K) Number: K140100
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 09/19/2017

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: 11/16/2018
• Device Model Number: TRUEMETRIX
• Device Catalogue Number: RE4H01-81
• Device Lot Number: MU2472
• 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: 08/24/2017
• Initial Report FDA Received Date: 09/19/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1