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

Model Number	TRUMETRXGO
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/06/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal report # (b)(4).Product not yet returned for evaluation.Most likely underlying root cause: mlc-58-user had an inaccurate reference: self: the person is using themselves as the reference or how they feel at the time they run the blood test.Test strip (b)(4).
Event or Problem Description
Consumer reported complaint for high blood glucose results the customer is concerned with all of the results obtained.The expected fasting blood glucose test result range is 140 to 150mg/dl.The customer feels well and did report symptoms.Medical attention is not reported as a result of the actual blood glucose results.The product is stored by customer according to specification in the bedroom.During the call on (b)(6) 2017, a back to back blood test was performed non-fasting by the customer and produced test results of 344 and 200mg/dl using true metrix go meter.The test strip lot manufacturer's expiration date is 11/30/2018 and open vial date is (b)(6) 2017.The meter memory was reviewed for previous test result history: (date/time not stored correctly).The 248mg/dl date: (b)(6) 2017 time:12:01 pm fasting, 300mg/dl date: (b)(6) 2017 time:6:32 pm fasting, 181mg/dl date: (b)(6) 2017 time:10:49 am fasting, 400mg/dl date: (b)(6) 2017 time:12:56 pm fasting, 211mg/dl date: (b)(6) 2017 time:11:06 pm fasting.The customer is calling because she feels that the results she is getting from the meter are reading high.

• Brand Name: TRUMETRXGO
• Common Device Name: BLOOD GLUCOSE SYSTEM
• Manufacturer (Section D): TRIVIDIA HEALTH, INC.; 2400 nw 55th court; fort lauderdale FL 33309
• MDR Report Key: 7071257
• Report Number: 1000113657-2017-02011
• Device Sequence Number: 13652999
• Product Code: NBW
• UDI-Device Identifier: 00021292009793
• UDI-Public: (01)00021292009793
• Combination Product (Y/N): N
• Initial Reporter State: AL
• PMA/510(K) Number: K143548
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 11/30/2017

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: TRUMETRXGO
• Device Catalogue Number: RF4H01-01
• Device Lot Number: MU2511
• 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: 11/06/2017
• Initial Report FDA Received Date: 11/30/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1