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

Model Number	TRUEMETRIX
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/10/2017
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 mlc-40-user's test strip had poor fill.Test strip (b)(4).
Event or Problem Description
Consumer reported complaint for lo blood glucose results.A friend is calling on behalf of the customer.The customer is concerned with the result of lo.The expected fasting blood glucose test result range is 100 to 120mg/dl.The customer 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.The test strip lot manufacturer's expiration date is 05/23/2018 and open vial date is (b)(6) 2017.The meter memory was reviewed for previous test result history.(date/time not stored correctly) (b)(6).The customer's friend is calling on behalf of the customer.The customer wanted to know what lo meant.I informed the customer that lo means that the results is reading below 20 mg/dl.I verified and confirmed with the customer that she is not experiencing any symptoms regarding her diabetes and does not need to seek any medical attention.The customer is storing the meter and test strips in the living room.The customer does not want to perform a back to back blood test due to wasting too many test strips because of the lo results.

• 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: 6757220
• Report Number: 1000113657-2017-01498
• Device Sequence Number: 11278887
• Product Code: NBW
• UDI-Device Identifier: 00096295126655
• UDI-Public: (01)00096295126655
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): 08/01/2017

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: MT2242
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/25/2017
• Was the Report Sent to FDA?: No
• Event Location: Home
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/10/2017
• Initial Report FDA Received Date: 08/01/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1