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

Model Number	TRUETRACK
Medical Device Problem Code	Battery Problem (2885)
Health Effect - Clinical Code	Tingling (2171)
Date of Event	03/28/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Returned meter evaluated with no defect found.Test strips not returned for evaluation.Most likely underlying root cause - strip inserted backwards or upside-down.(b)(4).Note: after several attempts manufacturer contacted customer on 4/7/2017 in a follow-up call in order to ensure the customer's condition since the initial call; customer had no symptoms and no medical attention was needed or reported since the previous call.
Event or Problem Description
The customer called stating the meter would not turn on.The customer also stated that it looks like the battery exploded in the meter.Customer stated she has not used the meter for a year and a half.During the call on (b)(6) 2017, it was verified that the battery had been installed properly with the + sign upwards.The customer's expected fasting blood glucose test result range was undisclosed.During the call on (b)(6) 2017, the customer stated she was having tingling in her hands and feet.Customer stated she thought her blood glucose was high.During the call on (b)(6) 2017, a back to back blood test was not performed by the customer.The product storage was undisclosed.The test strip lot manufacturer's expiration date is 02/28/2016; strips are expired.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: 6512948
• Report Number: 1000113657-2017-00713
• Device Sequence Number: 18998385
• Product Code: NBW
• UDI-Device Identifier: 00021292004576
• UDI-Public: (01)00021292004576
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 04/21/2017

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: 02/28/2016
• Device Model Number: TRUETRACK
• Device Catalogue Number: A4H01-81
• Device Lot Number: RP4258
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/05/2017
• Was the Report Sent to FDA?: No
• Event Location: Home
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/28/2017
• Initial Report FDA Received Date: 04/21/2017
• 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