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	05/16/2017
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 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 380mg/dl.The customer's expected fasting blood glucose test result range is 80 to 180mg/dl.The customer feels well and did not report any symptoms.Medical attention is not reported as a result of the actual blood glucose results.The product is stored according to specification.During the call on (b)(6) 2017, a back to back blood test was declined.The test strip lot manufacturer's expiration date is 06/20/2018 and open vial date is undisclosed.The meter memory was reviewed for previous test result history (date / time not set): the 216mg/dl (b)(6) 2017 11:58 am fasting: yes, the 199mg/dl (b)(6) 2017 06:34 pm fasting: yes, the 136mg/dl (b)(6) 2017 04:37 pm fasting: yes, the 363mg/dl (b)(6) 2017 01:44 pm fasting: yes, the 380mg/dl (b)(6) 2017 01:43 pm fasting: yes.Customer is concerned with high results.Result of concern is 380mg/dl.

• 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: 6629940
• Report Number: 1000113657-2017-00988
• Device Sequence Number: 16424812
• Product Code: NBW
• UDI-Device Identifier: 00021292007614
• UDI-Public: (01)00021292007614
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 06/09/2017

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: TRUEMETRIX
• Device Catalogue Number: RE4H01-81
• Device Lot Number: MU2309
• 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: 05/16/2017
• Initial Report FDA Received Date: 06/09/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1