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	04/20/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Product not yet returned for evaluation.Most likely underlying root cause: mlc-20-user's test strip had poor storage (bathroom).Test strip udi#(b)(4).Note: manufacturer contacted customer on (b)(6) 2018 in a follow-up call in order to ensure that the replacement products resolved the initial concern; customer stated that the replacement product is working to their satisfaction and they have not had any medical intervention since the last call.
Event or Problem Description
Consumer reported complaint for high blood glucose results.The customer is concerned with all of the results obtained.The expected fasting blood glucose test result range is 115 -116 mg/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 bathroom.The test strip manufacturer's expiration date is 07/25/2019 and open vial date is (b)(6) 2018.The meter memory was reviewed for previous test result history: result 1:328 mg/dl, date:(b)(6) 2018, time:02:14 pm, fasting; result 2:232 mg/dl, date:(b)(6) 2018, time:03:49 pm, fasting; result 3:241 mg/dl, date:(b)(6) 2018, time:11:02 pm, fasting; result 4:143 mg/dl, date:(b)(6) 2018, time:08:52 am, fasting; result 5:249 mg/dl, date:(b)(6) 2018, time:09:20 pm, fasting.The customer is stating that when he compares the results from his meter to his physician's meter (at scheduled routine visit) it is reading 100 points difference.

• 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: 7512736
• Report Number: 1000113657-2018-00549
• Device Sequence Number: 2019024
• Product Code: NBW
• UDI-Device Identifier: 00096295126600
• UDI-Public: (01)00096295126600
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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): 05/14/2018

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: MV2762
• 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: 04/20/2018
• Initial Report FDA Received Date: 05/14/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1