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	05/11/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Product not yet returned for evaluation.Most likely underlying root cause: mlc-18- user has high glucose value.(b)(4).Manufacturer contacted customer (several attempts) in a follow-up call to ensure that the replacement products resolved the initial concern - unable to establish contact with the customer at this time.Product notification letter sent to customer to contact customer care.
Event or Problem Description
Consumer reported complaint for hi display.Wife is calling on behalf of the customer.The customer is concerned with all of the results obtained.The expected fasting blood glucose test result range is 300mg/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 living room.During the call on (b)(6) 2018, a back to back blood test was performed fasting by the customer and produced test results of hi and hi using true metrix meter.The test strip lot manufacturer's expiration date is 06/16/2019 and open vial date is (b)(6) 2018.The meter memory was reviewed for previous test result history: result 1:hi date: (b)(6) 2018 time: 12:19 fasting, result 2:288mg/dl date: (b)(6) 2018 time:12:53am fasting, result 3:378mg/dl date: (b)(6) 2018 time:9:03pm fasting, result 4:319mg/dl date: (b)(6) 2018 time:11:36am fasting, result 5:169mg/dl date: (b)(6) 2018 time:12:19am fasting.Husband states he ran a blood test and got e-5 after 10 tries.Customer then run a blood test and got hi fasting.Customer states that he is a bad diabetic and she know that his glucose is high.Customer use 2 meters and one meter gave hi and the other meter shows e-5.Customer results are all over the carts.Customer normally glucose results in the 300mg.Customer went to the doctor for his normal checkup and then refer him to an endocrinologist.

• 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: 7570791
• Report Number: 1000113657-2018-00615
• Device Sequence Number: 19348640
• Product Code: NBW
• UDI-Device Identifier: 00052569138557
• UDI-Public: (01)00052569138557
• Combination Product (Y/N): N
• Initial Reporter State: AR
• PMA/510(K) Number: K140100
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 06/05/2018

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: MU2711
• 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: 05/11/2018
• Initial Report FDA Received Date: 06/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1