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

Model Number	TRUETRACK
Medical Device Problem Codes	High Test Results (2457); Device Displays Incorrect Message (2591)
Health Effect - Clinical Codes	Vomiting (2144); Loss of consciousness (2418)
Date of Event	10/18/2017
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.Customer satisfied with the product.Same product was used on the event of (b)(6) 2017.Most likely underlying root cause: mlc-118- user applied blood to strip before inserting strip into meter.(b)(4).
Event or Problem Description
Consumer complaint of e-3 error code.E-3 error occurred upon insertion of test strip into meter port and after blood sample applied to the test strip.At the time of the call customer feels well and did not report any symptoms.Medical attention is not reported currently as a result of blood glucose results.The expected fasting blood glucose test result range is undisclosed.The product storage location is undisclosed.During the call on (b)(6) 2017, a blood test was performed fasting by the customer and produced test results of 295mg/dl using true track meter.The test strip lot manufacturer's expiration date is 06/30/2019 and open vial date is undisclosed.The meter memory was not reviewed for previous test result history.The customer did report symptoms on (b)(6) 2017 and medical attention was reported as a result of the blood glucose results and reported symptoms on that day.Customer states he had ketoacidosis and was admitted to the hospital with a blood glucose reading of 519mg/dl.He states he was vomiting, was in and out of consciousness and does not remember the details.He was treated with iv medication.The customer was given new medications.Two new insulins, blood pressure medications, and heart medications.Customer states he was transferred to a nursing facility where he received therapy and was discharged on (b)(6) 2017.Customer states his right leg is weak due to the incident and received therapy for 52 days at a nursing facility.Customer stated he had to leave therefore limited information was provided.Customer is feeling well at the time of the call and denies symptoms of hyperglycemia.

• Brand Name: TRUETRACK
• Common Device Name: BLOOD GLUCOSE SYSTEM
• Manufacturer (Section D): TRIVIDIA HEALTH, INC.; 2400 nw 55th court; fort lauderdale FL 33309
• MDR Report Key: 7022526
• Report Number: 1000113657-2017-01935
• Device Sequence Number: 11136955
• Product Code: NBW
• UDI-Device Identifier: 00011822577540
• UDI-Public: (01)00011822577540
• Combination Product (Y/N): N
• PMA/510(K) Number: K032657
• 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): 11/10/2017

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: TRUETRACK
• Device Catalogue Number: A4H01-81
• Device Lot Number: RU5073
• 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: 10/18/2017
• Initial Report FDA Received Date: 11/10/2017
• 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