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

Model Number	TRUEMETRIX
Medical Device Problem Code	Device Displays Incorrect Message (2591)
Health Effect - Clinical Codes	Hyperglycemia (1905); Weakness (2145)
Date of Event	05/03/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Product not returned for evaluation.No replacement product needed at this time.Complaint resolved by training during the time of the call.Product is working as designed.Most likely underlying root cause: mlc-18- user has high glucose value.Test strip udi# (b)(4).Note: manufacturer contacted customer on (b)(4) 2018 in a follow-up call to ensure the customer's condition since the initial call; customer's condition had improved and did not currently have any diabetic symptoms.On (b)(6) 2018, due to the symptoms reported at the initial call, customer had called the ambulance and was taken to the hospital.Customer's blood glucose test result when at the hospital was 536 mg/dl.Customer was diagnosed with high blood sugar, a respiratory infection and uti and received fluids.Customer was at the hospital for six hours and left the same day ((b)(6) 2018).No new medications were prescribed.On (b)(6) 2018, customer performed blood test using the truemetrix meter and obtained a result of 259 mg/dl.
Event or Problem Description
Consumer reported complaint for e-5 code.The e-5 error occurred when the blood sample was absorbed.At the time of the call, the customer reported feeling lightheaded and weak.Customer declined medical attention at the time of the call but was advised to seek medical attention if needed.During the call on (b)(6) 2018, a blood test was performed by the customer non-fasting and produced test result of 529 mg/dl using truemetrix meter; customer had drank milk and took medicine prior to testing.The customer's expected non-fasting blood glucose test result range was undisclosed.The product storage was undisclosed.The test strip lot manufacturer's expiration date is 07/31/2019 and open vial date was 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: 7540410
• Report Number: 1000113657-2018-00590
• Device Sequence Number: 19298092
• 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: consumer
• Initial Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 05/24/2018

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 Expiration Date: 07/31/2019
• Device Model Number: TRUEMETRIX
• Device Catalogue Number: RE4H01-81
• Device Lot Number: MV2779
• 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: 05/03/2018
• Initial Report FDA Received Date: 05/24/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1