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); Urinary Frequency / Polyuria (2275); Polydipsia (2604)
Date of Event	04/11/2018
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 on (b)(4) 2018 in a follow-up call in order to ensure the customer's condition since the initial call;customer's condition has improved and no longer experiencing symptoms.The customer did seek medical attention on (b)(6) 2018 at the er for hyperglycemia (results were in the 300's at the hospital).Customer was put on an iv and given insulin.The customer was discharged on the same day.
Event or Problem Description
Consumer reported complaint for hi accompanied by symptoms.Daughter is calling on behalf of the customer.The expected fasting blood glucose test result range is undisclosed.The customer did report symptoms of increased urination, excessive thirst, and labored breathing.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 using the true track meter and produced a result of hi.The test strip lot manufacturer's expiration date is 06/18/2020 and open vial date is undisclosed.The meter memory was not reviewed for previous test result.Caller states her mother's meter read hi with strip vial rr4531 and i informed the customer the strips are expired.Customer had an additional vial ru5215 that was not expired and meter read hi.Customer has increased urination, excessive thirst, and labored breathing.Advised caller to call 911 and to seek medical attention for the customer.

• 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: 7490779
• Report Number: 1000113657-2018-00524
• Device Sequence Number: 13536593
• Product Code: NBW
• UDI-Device Identifier: 00096295129489
• UDI-Public: (01)00096295129489
• Combination Product (Y/N): N
• Initial Reporter State: CA
• PMA/510(K) Number: K032657
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 05/07/2018

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: RU5215
• 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: 04/11/2018
• Initial Report FDA Received Date: 05/07/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1