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

Model Number	TRUETRACK
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	Polydipsia (2604)
Date of Event	07/02/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Returned meter evaluated with no defect found.Test strip vial returned with expired test strips - unable to test.Most likely underlying root cause: mlc-12 product expired test strip udi# (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
Consumer reported complaint for hi blood glucose test results.Nurse is calling on behalf of the customer.The customer is concerned with tests results from results obtained of hi.The customer's expected fasting blood glucose test result range is 200 - 300 mg/dl.At the time of the call the customer reported feeling cold and thirsty.Nurse was with customer and stated she would call physician.During the call on (b)(6) 2018, a back to back blood test was not performed by the customer.The product is stored according to specification in the living room.The test strip lot manufacturer's expiration date is 04/30/2018; strips are expired and nurse was aware.Customer did not remember the open vial date.Customer did not have another vial of test strips.The meter memory was reviewed for previous test result history: (b)(6).The nurse says she is calling because she says that meter is old and believes that it is defective.Strips are expired and nurse is aware.No other strips are available.

• 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: 7710482
• Report Number: 1000113657-2018-00780
• Device Sequence Number: 19214433
• Product Code: NBW
• UDI-Device Identifier: 00096295129489
• UDI-Public: (01)00096295129489
• Combination Product (Y/N): N
• Initial Reporter State: WI
• PMA/510(K) Number: K032657
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 07/23/2018

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: 04/30/2018
• Device Model Number: TRUETRACK
• Device Catalogue Number: A4H01-81
• Device Lot Number: RS4814
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2018
• Was the Report Sent to FDA?: No
• Event Location: Home
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/02/2018
• Initial Report FDA Received Date: 07/23/2018
• 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