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

Model Number	TMETRIX PR
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	Fatigue (1849)
Date of Event	05/17/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Product not returned for evaluation.Customer declined replacement product at this time.Nurse states that the product work perfect with the other patients.Most likely underlying root cause: mlc-18- user has high glucose value.Test strip udi# (b)(4).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.Nurse states that the customer has not returned to the facility.
Event or Problem Description
Consumer reported complaint for hi display.Rn is calling on behalf of the customer.The expected fasting blood glucose test result range is undisclosed.The customer did report symptom of feeling tired.Medical attention is not reported as a result of the actual blood glucose results and reported symptoms.The product storage location is undisclosed.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 02/28/2019 and open vial date is undisclosed.The meter memory was not reviewed for previous test result history.Nurse called in to ask what does hi means, instructed nurse that it means that the blood sugar may be over 600 mg/dl.Nurse confirms that the meter works fine on other patients.Nurse states that the customer had symptoms of high blood sugar, she was taking care of that, could not continue to trouble shoot.

• Brand Name: TMETRIX PR
• Common Device Name: BLOOD GLUCOSE SYSTEM
• Manufacturer (Section D): TRIVIDIA HEALTH, INC.; 2400 nw 55th court; fort lauderdale FL 33309
• MDR Report Key: 7588260
• Report Number: 1000113657-2018-00636
• Device Sequence Number: 1555195
• Product Code: NBW
• UDI-Device Identifier: 00021292006099
• UDI-Public: (01)00021292006099
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• PMA/510(K) Number: K140100
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Nurse
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 06/11/2018

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: Health Professional
• Device Model Number: TMETRIX PR
• Device Catalogue Number: RE4H01P-43
• Device Lot Number: MU2608
• 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: 05/17/2018
• Initial Report FDA Received Date: 06/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1