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

Model Number	TRUEMETRIX
Medical Device Problem Codes	Unable to Obtain Readings (1516); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Blurred Vision (2137); Dizziness (2194); Urinary Frequency / Polyuria (2275)
Date of Event	08/16/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Product not yet returned for evaluation.Most likely underlying root cause: mlc-18- user has high glucose value test strip udi# (b)(4).Note: manufacturer contacted customer in a follow-up call to ensure the customer's condition since the initial call; customer did go to the hospital on (b)(6) 2018 and was diagnosed with hyperglycemia.Customer's bgr was 785mg/dl.His insulin dosage was increased.Customer was discharged on (b)(6) 2018.The customer condition has improved.The customer is not having any diabetic symptoms currently.Customer is comfortable with the glucose readings from the new replacement products.
Event or Problem Description
Consumer reported complaint for e-5 accompanied by symptoms.The expected fasting blood glucose test result range is undisclosed.The customer did report symptoms of feeling dizzy, blurred vision, frequent urination, fatigue and thirst.Medical attention is reported as a result of the actual blood glucose results and reported symptoms.The product storage location is undisclosed during the call on (b)(4) 2018, a blood test was performed by the customer and produced test results of e-5 true metrix meter.The test strip lot manufacturer's expiration date is 10/31/2019 and open vial date is date.The meter memory was not reviewed for previous test result history.While troubleshooting the error message did appear again.

• 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: 7862489
• Report Number: 1000113657-2018-00940
• Device Sequence Number: 1272160
• Product Code: NBW
• UDI-Device Identifier: 00087701426520
• UDI-Public: (01)00087701426520
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 09/10/2018

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: MV2882
• 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: 08/16/2018
• Initial Report FDA Received Date: 09/10/2018
• 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