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

Model Number	TRUEMETRIX
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/30/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Returned meter evaluated with no defect found.Test strips not returned for evaluation.Most likely underlying root cause of malfunction: user had an inaccurate reference test strip udi#:(b)(4).
Event or Problem Description
Consumer reported complaint for high blood glucose test results.The customer is concerned with tests results from results obtained of 187mg/dl.The customer's expected fasting blood glucose test result range is 85 to 98mg/dl.The customer feels well and did not report any symptoms.The product is stored according to specification in the bedroom.Medical attention is not reported as a result of the actual blood glucose results.During the call on (b)(6) 2016, a back to back blood test was performed by the customer fasting and produced test results of 127 and 115mg/dl using true metrix meter.The test strip lot manufacturer's expiration date is 12/31/2017 and open vial date is 11/01/2016.The meter memory was reviewed for previous test result history (date / time not set): 132mg/dl (b)(6) 2016 12:01 pm fasting: yes; 131mg/dl (b)(6) 2016 06:45 am fasting: yes; 158mg/dl (b)(6) 2016 06:43 am fasting: yes; 187mg/dl (b)(6) 2016 06:42 am fasting: yes; 129mg/dl (b)(6) 2016 06:28 am fasting: yes.Customer changed exercise routine; customer used to walk two miles and now he does not exercise as much.

• 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: 6202160
• Report Number: 1000113657-2016-02081
• Device Sequence Number: 1477818
• Product Code: NBW
• UDI-Device Identifier: 00041220001286
• UDI-Public: (01)00041220001286
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Replace
• Type of Report: Initial
• Report Date (Section B): 12/23/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: MT1874
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2016
• Was the Report Sent to FDA?: No
• Event Location: Home
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/30/2016
• Initial Report FDA Received Date: 12/23/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SECOND THERAPY