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	No Information (3190)
Date of Event	05/25/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4) product not returned for evaluation.No replacement product needed at this time.Complaint resolved by training during the time of the call.Product is working as designed.Most likely underlying root cause: mlc-14 - insufficient blood sample applied to strip (user) 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.Unable to send product letter.No address on file for the customer.
Event or Problem Description
Consumer reported complaint for e-2 accompanied by symptoms.The expected fasting blood glucose test result range is undisclosed.The customer did report symptom of feeling sick.Customer can't describe the symptoms.Medical attention is not reported as a result of the actual blood glucose results and symptoms.During the call on (b)(6) 2018, a blood test was performed by customer and produced test results of 249mg/dl using true metrix meter.The product is not stored by customer according to specification in the bathroom.The test strip lot manufacturer's expiration date is 06/22/2019 and open vial date is unknown.The meter memory was not reviewed for previous test result history.During the call meter read the blood 249mg/dl.Customer does not know if this is a good number for her or not.Customer was advised to speak to her doctor about her glucose readings and advised to call 911 or her doctor if her symptoms persist.

• 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: 7616022
• Report Number: 1000113657-2018-00663
• Device Sequence Number: 1695166
• Product Code: NBW
• UDI-Device Identifier: 00010939722447
• UDI-Public: (01)00010939722447
• 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): 06/19/2018

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: MV2724
• 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: 05/25/2018
• Initial Report FDA Received Date: 06/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1