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	No Information (3190)
Date of Event	06/28/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal report: (b)(4).Meter and test strips were not returned for evaluation.Most likely underlying root cause: mlc-18: user has high glucose value.Test strips udi: (b)(4).Note: manufacturer contacted customer in a follow-up call to ensure that the customer condition improved - unable to establish contact with customer at this time.
Event or Problem Description
Consumer reported complaint for hi display.Nurse from urgent care facility is calling on behalf of the customer.The expected fasting blood glucose test result range is undisclosed.Customer was having symptoms.Symptoms were not disclosed.Medical attention is reported as a result of the actual blood glucose results.The product storage location is undisclosed.The test strip lot manufacturer's expiration date is 02/29/2020 and open vial date is undisclosed.The facility's meter memory was not reviewed for previous test result history.

• 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: 8818305
• Report Number: 1000113657-2019-00760
• Device Sequence Number: 3205686
• Product Code: NBW
• UDI-Device Identifier: 10612479210254
• UDI-Public: (01)10612479210254
• 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: other
• Initial Reporter Occupation: Nurse
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 07/23/2019

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 Expiration Date: 02/29/2020
• Device Model Number: TMETRIX PR
• Device Catalogue Number: RE4H01P-43
• Device Lot Number: MV2917
• 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: 06/28/2019
• Initial Report FDA Received Date: 07/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1