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

Model Number	TRUEMETRIX
Medical Device Problem Codes	High Test Results (2457); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hyperglycemia (1905); Nausea (1970)
Date of Event	09/26/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Product not returned for evaluation.Customer declined replacement product at this time.Most likely underlying root cause: mlc-18- user has high glucose value.Test strip udi# (b)(4).Note: manufacturer contacted customer on 10/1/2018 in a follow-up call to ensure the customer's condition since the initial call; customer went to er on (b)(6) 2018 and was admitted to the hospital.Customer says blood sugar result was 1400mg/dl upon admission to the hospital.Customer was diagnosed with hyperglycemia and was treated with insulin, antibiotics and iv fluids.Customer was discharged on (b)(6) 2018 and is no longer experiencing symptoms.Customer states she is feeling better and that the meter is working as intended.
Event or Problem Description
Consumer reported complaint for e-5 after blood is applied accompanied by symptoms.Mother is calling on behalf of the customer.The expected fasting blood glucose test result range is undisclosed.The customer did report symptoms of feeling nauseous.Medical attention is reported as a result of the actual blood glucose results and reported symptoms.The product storage location is undisclosed.The test strip lot manufacturer's expiration date is 07/31/2019 and open vial date is undisclosed.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: 7992060
• Report Number: 1000113657-2018-01087
• Device Sequence Number: 1255202
• Product Code: NBW
• UDI-Device Identifier: 00050428275283
• UDI-Public: (01)00050428275283
• Combination Product (Y/N): N
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 10/22/2018

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: MV2778
• 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: 09/26/2018
• Initial Report FDA Received Date: 10/22/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization