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

Model Number	TRUEMETRIX
Medical Device Problem Code	Incorrect Or Inadequate Test Results (2456)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/24/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Product not yet returned for evaluation.Most likely underlying root cause: (b)(4) -user had poor technique test strip udi# (b)(4).
Event or Problem Description
Consumer reported complaint for erratic blood glucose results.The customer is concerned with results obtained of 88 and 164mg/dl.The expected fasting blood glucose test result range is 100 to 120mg/dl.The customer feels well and did not 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 fasting by the customer and produced test results of 90 and 164mg/dl using true metrix meter.The test strip lot manufacturer's expiration date is 11/17/2018 and open vial date is (b)(6) 2017.The meter memory was reviewed for previous test result history: (date/time not stored correctly) result 1 : 105 mg/dl date: (b)(6) time: 4:19 pm fasting.Result 2 : 88 mg/dl date: (b)(6) time: 4:18 pm fasting.Result 3 : 136 mg/dl date: (b)(6) time: 4:16 pm fasting.Result 4 : 164 mg/dl date: (b)(6) time: 4:09 pm fasting.Result 5 : 164 mg/dl date: (b)(6) time: 3:35 pm fasting.Customer states that when she performs back to back blood tests, her results are erratic in nature.All blood glucose tests are normally done fasting.Customer states that she tests up to 4 times per day.Time not currently set up correctly in the meter.
Additional Manufacturer Narrative
Internal report # (b)(4).Returned meter evaluated with no defect found.Test strips not 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 erratic blood glucose results.The customer is concerned with results obtained of 88 and 164mg/dl.The expected fasting blood glucose test result range is 100 to 120mg/dl.The customer feels well and did not 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 fasting by the customer and produced test results of 90 and 164mg/dl using true metrix meter.The test strip lot manufacturer's expiration date is 11/17/18 and open vial date is 10/16/2017.The meter memory was reviewed for previous test result history: (date/time not stored correctly) (b)(6).Customer states that when she performs back to back blood tests, her results are erratic in nature.All blood glucose tests are normally done fasting.Customer states that she tests up to 4 times per day.Time not currently set up correctly in the meter.

• 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: 7036831
• Report Number: 1000113657-2017-01959
• Device Sequence Number: 16453459
• Product Code: NBW
• UDI-Device Identifier: 10612479210261
• UDI-Public: (01)10612479210261
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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,Followup
• Report Date (Section B): 12/05/2017

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: MU2476
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2017
• Was the Report Sent to FDA?: No
• Event Location: Home
• Initial Date Received by Manufacturer: 10/24/2017
• Supplement Date Received by Manufacturer: 10/24/2017
• Initial Report FDA Received Date: 11/16/2017
• Supplement Report FDA Received Date: 12/05/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1