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	Loss of consciousness (2418)
Date of Event	07/17/2017
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.Test strip udi# (b)(4).Note: manufacturer contacted customer on 7/19/2017 in a follow-up call in order to ensure the customer's condition since the initial call; customer condition improved.No symptoms or medical attention reported since the original call.Customer satisfied with the replacement product.
Event or Problem Description
Consumer reported complaint for high blood glucose results.Accompanied by symptoms.The customer is concerned with all of the result obtained.The expected fasting blood glucose test result range is 80 to 95mg/dl.The customer did report symptoms of a diabetic coma.Medical attention is reported as a result of the actual blood glucose results and reported symptoms.The product is stored by customer according to specification.The test strip lot manufacturer's expiration date is 04/30/2019 and open vial date is within the month of (b)(6) 2017.The meter memory was reviewed for previous test result history: the 510mg/dl (b)(6) 2017 02:25 pm fasting: yes, 446mg/dl (b)(6) 2017 01:34 am fasting: yes, 258mg/dl (b)(6) 2017 12:00 am fasting: yes, 340mg/dl (b)(6) 2017 12:33 am fasting: yes, 319mg/dl (b)(6) 2017 02:34 pm fasting: yes.The customer call in regards to getting high result on the meter that caused him to go to go to the ambulance.The customer states on (b)(6) 2017 he had taken his blood sugar in the evening before bed and the results was 340mg/dl.He took only half of his insulin and went to bed.He had a dentist appointment the next day.The alarm kept going off and his wife realized something was wrong and he was in a diabetic coma.This occurred between 8:00-8:15am.His wife called the paramedics.They took his blood test and the result was 31mg/dl.They gave him shots and took him to the hospital.He does not know the result at the hospital since he cannot remember anything.He left the hospital on (b)(6) 2017 between 2-3pm.When he left the hospital, his blood result was 126mg/dl.There was not hurt.He stated the meter was giving him high blood results and he had no symptoms of high sugar.The code chip matches the test strips.

• 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: 6787896
• Report Number: 1000113657-2017-01538
• Device Sequence Number: 150158
• Product Code: NBW
• UDI-Device Identifier: 00096295129489
• UDI-Public: (01)00096295129489
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 08/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Model Number: TRUETRACK
• Device Catalogue Number: A4H01-81
• Device Lot Number: RT5026
• 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: 07/17/2017
• Initial Report FDA Received Date: 08/11/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization