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

Model Number	TRUETRACK
Medical Device Problem Code	Unable to Obtain Readings (1516)
Health Effect - Clinical Codes	Dizziness (2194); Lethargy (2560)
Date of Event	02/06/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Note: manufacturer contacted customer on (b)(6) 2019 in a follow-up call to ensure the customer's condition since the initial call; customer states at the time of call that she was having symptoms.Customer sates that she obtained a result of 80mg/dl.She states that she feels dizzy and sleepy and that she was going to seek medical intervention.Another follow up call was made by the manufacturer on 2/14/2019; customer still feel the same (sleepy, tired, dizzy).Her caregiver took her for blood work this morning because she had an appointment.Did not have medical intervention related to blood sugar.No diagnosis reported.There were additional tests performed with alleged defective meter and customer was satisfied.
Event or Problem Description
Consumer reported complaint for e-3 accompanied by symptoms.Caller is calling on behalf of the customer.The expected fasting blood glucose test result range is undisclosed.The customer did report symptoms of feeling dizzy and sleepy.Medical attention is not reported as a result of the actual blood glucose results.The product is not stored according to specification in a plastic bag outside of the vial.The test strip lot manufacturer's expiration date is undisclosed and open vial date is undisclosed.No test strip vial available.The meter memory was not reviewed for previous test result history.

• 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: 8391009
• Report Number: 1000113657-2019-00177
• Device Sequence Number: 1651611
• Product Code: NBW
• UDI-Device Identifier: 00096295129489
• UDI-Public: (01)00096295129489
• 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): 03/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: TRUETRACK
• Device Catalogue Number: A4H01-81
• Device Lot Number: N/A
• 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: 02/06/2019
• Initial Report FDA Received Date: 03/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1