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	Sweating (2444); Lethargy (2560)
Date of Event	08/29/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Product not returned for evaluation.Customer declined replacement product at this time.Replaced only the test strips.Most likely underlying root cause: mlc-22-client is testing with expired test strips (b)(4).Manufacturer contacted customer (several attempts) in a follow-up call in order to ensure the customer's condition since the initial call - unable to establish contact with the customer at this time.Product notification letter sent to customer to contact customer care.
Event or Problem Description
Consumer reported complaint for e-3 accompanied by symptoms.The expected fasting blood glucose test result range is undisclosed.The customer did report symptoms of feeling sweaty and lethargic.Medical attention is not reported as a result of the actual blood glucose results and reported symptoms.The product storage location is undisclosed.The test strip lot manufacturer's expiration date is 12/31/15 and open vial date is undisclosed.The meter memory was not reviewed for previous test result history.Customer needed assistance with the meter regarding the e3 error.The error appeared as soon as the test strip was inserted in the meter.Strips are expired.Customer states that she went to the pharmacy to get strips, but they are not available.Customer states that she is sweaty and lethargic.Customer declined a replacement meter and only wants to be sent test strips.

• 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: 7902057
• Report Number: 1000113657-2018-00965
• Device Sequence Number: 168315
• Product Code: NBW
• UDI-Device Identifier: 00021292001971
• UDI-Public: (01)00021292001971
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 09/24/2018

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 Expiration Date: 12/31/2015
• Device Model Number: TRUETRACK
• Device Catalogue Number: A4H01-81
• Device Lot Number: RP4220
• 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: 08/29/2018
• Initial Report FDA Received Date: 09/24/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1