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 Codes	Anxiety (2328); Sweating (2444); Confusion/ Disorientation (2553)
Date of Event	05/22/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Product not returned for evaluation.Customer disconnected the call; unable to send replacement product.Most likely underlying root cause: mlc-21- improper technique of obtaining or applying blood sample.Test strip udi# (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 multiple error messages accompanied by symptoms.The expected fasting blood glucose test result range is 180 to 187mg/dl.The customer did report symptoms of confusion, nervousness, sweatiness, mood swings, slurred speech.Medical attention is not reported as a result of the actual blood glucose results and reported symptoms.The product is stored by customer according to specification in the living room.During the call on (b)(6) 2018, a back to back blood test was not performed.The test strip lot manufacturer's expiration date is 06/14/2019 and open vial date is undisclosed.The meter memory was not reviewed for previous test result history.Customer called in and states that the meter is giving multiple errors messages.Customer is not sure what the error messages were.Customer wasted several strips trying to run a blood test.Customer is currently having any symptoms pertaining to diabetes at this time suc as confusion, nervousness, sweatiness, mood swings, slurred speech.Customer's normal fasting range180mg/dl-187mg/dl fasting.Verified customer is storing the strips properly in living room.Customer declined to go through the proper techniques to perform a blood test.Error message was not confirmed.Customer declined to retest and disconnected call.Will follow back with customer.

• 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: 7598645
• Report Number: 1000113657-2018-00647
• Device Sequence Number: 1186852
• Product Code: NBW
• UDI-Device Identifier: 00096295126655
• UDI-Public: (01)00096295126655
• 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): 06/13/2018

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 Model Number: TRUEMETRIX
• Device Catalogue Number: RE4H01-81
• Device Lot Number: MU2710
• 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: 05/22/2018
• Initial Report FDA Received Date: 06/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1