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	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/17/2018
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: mlc-58-user had an inaccurate reference: self: the person is using themselves as the reference or how they feel at the time they run the blood test.(b)(4).Note: manufacturer contacted customer (several attempts) in a follow-up call in order to ensure that the replacement products resolved the initial concern - 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 initially reported complaint for e-3 error: used test strip, test strip outside of vial too long, sample on top of test strip.The e-3 error had occurred once the test strip was inserted into the meter.During the call on (b)(6) 2018, a back to back blood test was performed by the customer fasting and produced test results of hi and hi using truetrack meter.The customer did not know her expected blood glucose test result range.The customer feels well and did not report any symptoms.Medical attention is not reported as a result of the actual blood glucose results.The customer had just purchased the test strips on day of call; customer was informed of proper storage locations.The test strip lot manufacturer's expiration date is 4/13/2020 and open vial date is (b)(6) 2018.Customer was only able to obtain two results from the meter memory: result 1 : hi mg/dl date: (b)(6) 2018 time:07:09 pm fasting, result 2 : hi mg/dl date: (b)(6) 2018 time:07:09pm fasting.Customer called in states the meter is reading e-3 while conducting troubleshooting customer received an hi display.Customer states the meter read hi fasting and another hi fasting within 15 minutes of each other.Customer states she does not know her normal fasting range is.Customer could only obtain two readings of hi in history of meter.

• 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: 7242176
• Report Number: 1000113657-2018-00144
• Device Sequence Number: 13749264
• Product Code: NBW
• UDI-Device Identifier: 00011822577540
• UDI-Public: (01)00011822577540
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 02/05/2018

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: 04/13/2020
• Device Model Number: TRUETRACK
• Device Catalogue Number: A4H01-81
• Device Lot Number: RU5177
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2018
• Was the Report Sent to FDA?: No
• Event Location: Home
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/17/2018
• Initial Report FDA Received Date: 02/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1