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

Model Number	TRUEMETRIX
Medical Device Problem Codes	Unable to Obtain Readings (1516); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Blurred Vision (2137)
Date of Event	10/11/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Product not returned for evaluation.No replacement product needed at this time.Complaint resolved by training during the time of the call.Product is working as designed.Most likely underlying root cause: mlc-62-user had poor technique test strip udi# (b)(4).Note: customer's condition has improved.Customer states that he is feeling much better- no longer experiencing symptoms.Customer went to the er on (b)(6) 2018.Customer was not hospitalized.Customer stated that when he arrived at the hospital, they took his blood sugar and a urine test.Customer was released the same day and given an rx for metformin.Customer was diagnosed with type 2 diabetes.Customer stated that they just took a urine and blood test.Results were 271mg/dl fasting.Customer was discharged the same day.No further medical attention is required.
Event or Problem Description
Consumer reported complaint for e-3 accompanied by symptoms.The expected fasting blood glucose test result range is undisclosed.Customer not feeling physically well and report symptoms of blurry vision and dry mouth.Customer has not been diagnosed but will visit a doctor tomorrow for treatment for hyperglycemia.Medical attention is not reported as a result of the actual blood glucose results and reported symptoms.The product is stored by customer according to specification in the dining room.During call on (b)(6) 2018, back to back blood test was performed non-fasting by the customer and produced test results of 341mg/dl using true metrix meter.The test strip lot manufacturer's expiration date is date and open vial date is date.The meter memory was not reviewed for previous test result history.

• 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: 8041540
• Report Number: 1000113657-2018-01136
• Device Sequence Number: 1643608
• Product Code: NBW
• UDI-Device Identifier: 00021292006082
• UDI-Public: (01)00021292006082
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 11/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Model Number: TRUEMETRIX
• Device Catalogue Number: RE4H01-81
• Device Lot Number: MV2905
• 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: 10/11/2018
• Initial Report FDA Received Date: 11/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1