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	Dizziness (2194); Shaking/Tremors (2515)
Date of Event	02/18/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Returned meter evaluated with defect found.Due to the complaint indicates meter error, further investigation of the returned test strips is not required.Root cause: broken solder joint on code key connector "j2" from user mechanical stress.(b)(4).Note: 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
Customer is calling regarding "----" on meter display when inserting a new test strip.The customer's expected fasting/non-fasting blood glucose test result range was undisclosed.During the call on (b)(6) 2017, the customer stated she felt shaky and dizzy and believed that her glucose reading was low but that she cannot check due to the code of "----".Customer was advised to seek medical attention; customer declined and stated she would have some protein and wanted to continue to troubleshoot the meter.During the call on (b)(6) 2017, the customer took out the code chip as well as the battery and waited about two minutes before re-inserting the battery and code chip.When the customer inserted a new strip, the meter displayed "----".The customer stated she did not have another vial of test strips.The product storage was undisclosed.The test strip lot manufacturer's expiration date is 02/25/2019 and open vial date was undisclosed.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: 6408069
• Report Number: 1000113657-2017-00491
• Device Sequence Number: 797628
• Product Code: NBW
• UDI-Device Identifier: 00096295129489
• UDI-Public: (01)00096295129489
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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: Replace
• Type of Report: Initial
• Report Date (Section B): 03/15/2017

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: 02/25/2019
• Device Model Number: TRUETRACK
• Device Catalogue Number: A4H01-81
• Device Lot Number: RT4974
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2017
• Was the Report Sent to FDA?: No
• Event Location: Home
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/18/2017
• Initial Report FDA Received Date: 03/15/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SECOND THERAPY