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

Model Number	TRUEMETRIX
Medical Device Problem Code	Device Displays Incorrect Message (2591)
Health Effect - Clinical Code	Polydipsia (2604)
Date of Event	04/25/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Product not returned for evaluation.No replacement product needed at this time.Problem solved at the time of the call by training.Product worked as intended.Most likely underlying root cause of malfunction: user applied blood to strip before inserting strip into meter (b)(4).Note: manufacturer contacted customer (several attempts) in a follow-up call in order to ensure the customer's condition since the initial call - unable to establish contact with the customer at this time.
Event or Problem Description
Consumer reported complaint for e-3 upon insertion and symptoms.The customer is concerned with tests results from results obtained of e-3 accompanied by symptoms.The customer's expected fasting blood glucose test result range is 250 to 300mg/dl.The customer did report symptom of dry mouth.Medical attention is not reported as a result of the actual blood glucose results and reported symptoms.On (b)(6) 2017, a blood test was done fasting and produced a result of 218mg/dl using a true metrix meter.Product problem resolved by training during the time of the call.The product is stored according to specification in the bedroom.The test strip lot manufacturer's expiration date is 06/27/2018 and open vial date is undisclosed.The meter memory was not reviewed for previous test result history.

• 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: 6578817
• Report Number: 1000113657-2017-00873
• Device Sequence Number: 615759
• Product Code: NBW
• UDI-Device Identifier: 00087701426254
• UDI-Public: (01)00087701426254
• Combination Product (Y/N): N
• 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): 05/19/2017

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 Model Number: TRUEMETRIX
• Device Catalogue Number: RE4H01-81
• Device Lot Number: MU2304
• 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: 04/25/2017
• Initial Report FDA Received Date: 05/19/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1