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

Model Number	TRUETRACK
Medical Device Problem Code	Device Displays Incorrect Message (2591)
Health Effect - Clinical Codes	Fainting (1847); Hypoglycemia (1912)
Date of Event	01/15/2018
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-68- user did not insert code key.Test strip udi# (b)(4).
Event or Problem Description
Consumer reported complaint for e-8 past adverse event accompanied by symptoms.Caregiver is calling on behalf of the customer.The expected fasting blood glucose test result range is undisclosed.The customer feels well at time of call but did report symptoms of collapsing prior to today's date.Medical attention is reported as a result of reported symptoms.The product storage location is undisclosed.During the call on (b)(6) 2018, a blood test was performed non-fasting by the customer and produced test results of 95 mg/dl non-fasting using true track meter.The test strip lot manufacturer's expiration date is 04/30/2020 and open vial date is undisclosed.The meter memory was not reviewed for previous test result history.Caregiver explains when she came to see him, she found him collapsed on the ground and called 9-1-1.Per caregiver, customer was hypoglycemic and collapsed on the ground.Customer went to the hospital and was diagnosed with hypoglycemia.Caregiver refused to provide information such as, time and date of incident, lab results and glucose meter being used at the time.Customer is feeling fine at the time of call.No other medical attentions reported at the time of 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: 7247283
• Report Number: 1000113657-2018-00152
• Device Sequence Number: 16178156
• Product Code: NBW
• UDI-Device Identifier: 00052569132463
• UDI-Public: (01)00052569132463
• 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: other
• Initial Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 02/07/2018

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: RU5188
• 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: 01/15/2018
• Initial Report FDA Received Date: 02/07/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1