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

Model Number	TRUETRACK
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Codes	Hyperglycemia (1905); No Code Available (3191)
Date of Event	03/09/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(manufacturer narrative = t, corrected data = f) (b)(4).Product not returned for evaluation.No replacement product needed at this time most likely underlying root cause: mlc-18- user has high glucose value test strip (b)(4).Note: manufacturer contacted customer on 3/14/2018 in a follow-up call in order to ensure the customer's condition since the initial call; customer states that he was hospitalized on (b)(6) 2018 for hyperglycemia.Was treated with iv insulin.Customer is not sure of what his actual blood glucose result was at the hospital.Customer was discharged on (b)(6) 2018.He is no longer experiencing symptoms.Customer states he does not need a replacement for he believes his meter is reading accurately.
Event or Problem Description
Consumer reported complaint for high blood glucose results.The customer is concerned with results obtained of 574 mg/dl.The expected fasting blood glucose test result range is undisclosed.The customer did report symptoms of slurred speech.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)(6) 2018, a blood test was performed fasting by the customer and produced test results of 574 mg/dl using true track meter.The test strip lot manufacturer's expiration date is 05/31/2020 and open vial date is undisclosed.The meter memory was not reviewed for previous test result history.Customer called in for assistance running a blood test.Customer reported symptoms of slurred speech.Upon blood test customer read reading of 574 mg/dl fasting.Customer was not able to continue the call.

• 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: 7391971
• Report Number: 1000113657-2018-00391
• Device Sequence Number: 1095182
• 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): 04/03/2018

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: TRUETRACK
• Device Catalogue Number: A4H01-81
• Device Lot Number: RU5212
• 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: 03/09/2018
• Initial Report FDA Received Date: 04/03/2018
• 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