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 Codes	Blurred Vision (2137); No Code Available (3191)
Date of Event	07/28/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
( internal report # (b)(4)).Returned meter evaluated with no defect found.Test strips not returned for evaluation.Most likely underlying root cause of malfunction: mlc-18 user has high glucose value.Test strip udi#: (b)(4).(b)(4).No code available - customer reported symptom of dry mouth.Note: at follow up call on (b)(6) 2017, the customer stated her condition had improved and that she did not currently have any diabetic symptoms.The customer stated that on (b)(6) 2017 she had gone to the er due to the meter reading hi.Customer stated that her blood test result when at the er using the doctor's meter was hi.Customer was diagnosed with hyperglycemia and was given iv fluids and insulin.There were no new medications or healthcare program suggested.Customer stated she left the hospital on (b)(6) 2017.Blood test performed with the truetrack meter produced result of 600 mg/dl.Customer stated the meter continues to read hi and sometimes gives results.
Event or Problem Description
Consumer reported complaint for hi blood glucose test results.The customer is concerned with tests results from results obtained of hi.The customer's expected fasting blood glucose test result range is 105 - 200 mg/dl.At the time of the call, the customer reported symptoms of blurry vision and dry mouth.Customer stated she would seek medical attention.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 09/16/2018 and open vial date was undisclosed.The meter memory was reviewed for previous test result history: hi (b)(6) 2017 2:30pm, 477mg/dl (b)(6) 2017 9:10pm fasting, 3:551mg/dl (b)(6) 2017 7:51am fasting, 4:483mg/dl (b)(6) 2017 6:12pm fasting, 5:508mg/dl (b)(6) 2017 1:27pm fasting.Memory concerns:hi (b)(6) 2017 6:30pm customer called stating the meter is reading hi.Customer has dry mouth and blurry vision.Explained to customer that an hi is an indication that he blood sugar is over 600mg/dl.Customer will seek medical attention.

• 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: 6806946
• Report Number: 1000113657-2017-01587
• Device Sequence Number: 150336
• Product Code: NBW
• UDI-Device Identifier: 00087701405570
• UDI-Public: (01)00087701405570
• 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): 08/21/2017

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 Expiration Date: 09/16/2018
• Device Model Number: TRUETRACK
• Device Catalogue Number: A4H01-81
• Device Lot Number: RT4896
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/09/2017
• Was the Report Sent to FDA?: No
• Event Location: Home
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/28/2017
• Initial Report FDA Received Date: 08/21/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1