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	10/20/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal report # (b)(4).Product not yet 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.
Event or Problem Description
Consumer reported complaint for high blood glucose test results.The customer is concerned with tests results from fasting meter to meter comparison of 350 mg/dl using truetrack meter and 94 mg/dl using dr.'s device.The customer is also concerned with results obtained of 233 and 134 mg/dl.The customer stated he is not diabetic and that his expected fasting blood glucose test result range is 60 - 115 mg/dl.At the time of the call, the customer felt well and did not report any symptoms.The customer stated that about three weeks prior to the call he felt that the meter was giving high results.The customer went to see his doctor due to his concern about the high results obtained.The customer did not report any symptoms or illness, he was only concerned with the high results and that lead him to contact his doctor.The customer did not receive any treatment while at the doctor's office.The doctor recommended that a different meter be used.During the call on (b)(6) 2017, a back to back blood test was not performed by the customer; the customer did not have any test strips.The meter memory was reviewed for previous test result history (result of 350 mg/dl was not confirmed in the meter memory): (b)(6).

• 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: 7029272
• Report Number: 1000113657-2017-01938
• Device Sequence Number: 16524703
• Product Code: NBW
• UDI-Device Identifier: 00050428264706
• UDI-Public: (01)00050428264706
• 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): 11/14/2017

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 Model Number: TRUETRACK
• Device Catalogue Number: A4H01-81
• Device Lot Number: N/A
• 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: 10/20/2017
• Initial Report FDA Received Date: 11/14/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1