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	01/19/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Product not yet returned for evaluation.Most likely underlying root cause: mlc-58-user had an inaccurate reference: self: the person is using themselves as the reference or how they feel at the time they run the blood test.(b)(4).Manufacturer spoke with the customer on several occasions in order to ensure that the replacement products resolved the initial concern; customer received the replacement product.Customer also states that he went to the hospital because customer wasn't feeling well.Customer was diagnosed and treated for other condition not related to diabetes or our product.
Event or Problem Description
Consumer reported complaint for lo blood glucose results.The expected fasting blood glucose test result range is undisclosed.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 storage location is undisclosed.During the call, a back to back blood test was not performed.The test strip lot manufacturer's expiration date is undisclosed and open vial date is undisclosed.The meter memory was not reviewed for previous test result history.Customer states the meter read lo fasting and took two glucose tablets.Customer states he tested with his other meter after taking the glucose tablets and meter read 590mg/dl non-fasting.Customer denies the need for medical attention at the time of call and denies signs and symptoms of hyperglycemia at the time of call.Offered to replace the meter and customer refused.Customer was using another meter and no longer using the true metrix meter and he was happy with the other meter.Customer declined the replacement and hung up.Customer called back about getting the meter replacement overnight.

• 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: 7268299
• Report Number: 1000113657-2018-00179
• Device Sequence Number: 16512915
• Product Code: NBW
• UDI-Device Identifier: 00011822445610
• UDI-Public: (01)00011822445610
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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): 02/13/2018

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: N/A
• 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: 01/19/2018
• Initial Report FDA Received Date: 02/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1