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

Model Number	TRUETRACK
Medical Device Problem Codes	High Test Results (2457); Device Displays Incorrect Message (2591)
Health Effect - Clinical Codes	Blurred Vision (2137); Urinary Frequency / Polyuria (2275); Polydipsia (2604)
Date of Event	08/21/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal report # (b)(4).Product not returned for evaluation.No replacement product needed at this time.Product is working as designed.Customer satisfied with the product.Most likely underlying root cause of malfunction: mlc-18 user has high glucose value.Test strip udi# (b)(4).Note: manufacturer contacted customer on 8/22/2017 in a follow-up call in order to ensure the customer's condition since the initial call; customer advised she feels better and is no longer experiencing symptoms.She did however seek medical attention on (b)(6) 2017.Customer went to the er where she was diagnosed with hyperglycemia.Her blood glucose reading at the hospital was 950mg/dl.She was treated with iv fluids and insulin and was released the same day.
Event or Problem Description
Consumer reported complaint for e-5 blood glucose results accompanied by symptoms.The expected fasting blood glucose test result range is 250 to 300mg/dl.The customer did report symptoms of fatigue, excess urination, thirst and blurry vision.Medical attention is reported as a result of the actual blood glucose results and reported symptoms.The product storage location is undisclosed.The test strip lot manufacturer's expiration date is 02/23/2019 and open vial date is undisclosed.The meter memory was reviewed for previous test result history.Customer is feeling like her sugar is very high, she had a panic attack from being in the heat and states that may raise her sugar, also that she is on her menstrual cycle and being on her cycle may raise her sugar up an extra 100mg/dl resulting in an average of 250-300mg/dl.Instructed customer to seek medical attention asap.Customer states she will call for help.Informed customer i will call her in 30 min.On 8/21/2017 a follow up call back was made: unable to reach customer- left voicemail.

• 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: 6831551
• Report Number: 1000113657-2017-01641
• Device Sequence Number: 13668447
• Product Code: NBW
• UDI-Device Identifier: 00021292001971
• UDI-Public: (01)00021292001971
• Combination Product (Y/N): N
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 08/30/2017

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: RT4972
• 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: 08/21/2017
• Initial Report FDA Received Date: 08/30/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1