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	10/10/2017
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: (b)(4) - user has high glucose value test strip udi# (b)(4).
Event or Problem Description
Consumer reported complaint for hi blood glucose results.The customer is concerned with results obtained results of hi.The expected fasting blood glucose test result range is 110 to 150mg/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 not stored by customer according to specification in the kitchen.The test strip lot manufacturer's expiration date is 11/24/2018 and open vial date is (b)(6) 2017.The meter memory was reviewed for previous test result history: result 1 : 82mg/dl date: (b)(6) 2017 time: 8:14am fasting.Result 2 : 285mg/dl date: (b)(6) 2017 time: 5:17am fasting.Result 3 : 551mg/dl date: (b)(6) 2017 time: 2:18pm fasting.Result 4 : hi date: (b)(6) 2017 time: 12:23pm fasting.Result 5 : hi date: (b)(6) 2017 time: 10:13pm fasting.Customer called about e-5, while explaining that it may be a high blood sugar reading (over 600mg/dl) customer mentioned that she also obtained an hi.Customer feels fine and denies symptoms related to diabetes at the time of call.Customer states her last a1c was 7.3 (163mg/dl) and that her fasting range is 110-150mg/dl.Customer is not concerned with hi since she was not experiencing symptoms of hyperglycemia at the time of higher readings.Customer states she took her insulin and kept monitoring her sugar.Customer did not have control test.Did not run a back to back blood test since customer is not fasting.

• 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: 6988306
• Report Number: 1000113657-2017-01877
• Device Sequence Number: 944638
• Product Code: NBW
• UDI-Device Identifier: 00096295126655
• UDI-Public: (01)00096295126655
• Combination Product (Y/N): N
• Initial Reporter State: NE
• 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): 10/30/2017

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: MU2480
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2017
• Was the Report Sent to FDA?: No
• Event Location: Home
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/10/2017
• Initial Report FDA Received Date: 10/30/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1