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

Model Number	TRUETRACK
Medical Device Problem Code	Device Displays Incorrect Message (2591)
Health Effect - Clinical Codes	Hyperglycemia (1905); Urinary Frequency / Polyuria (2275)
Date of Event	12/28/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Product not returned for evaluation.Customer declined replacement product at this time.Complaint resolved by training during the time of the call.Product is working as designed.Most likely underlying root cause: mlc-103 - finger removed from strip before strip had sufficient time to fill test strip (b)(4).At call back on (b)(6) 2017, the customer's condition had improved and the customer did not currently have any diabetic symptoms.Due to the symptoms of dry mouth and urinary frequency reported on the initial call, the customer had gone to the emergency room on (b)(6) 2017.His vital signs had been taken upon his arrival and they were normal; customer did not remember what they were.Customer's blood glucose test result upon arrival was 500 mg/dl non-fasting.The diagnosis was hyperglycemia.Customer received an iv bag and insulin as treatment, he did not know how much.The customer was discharged the same day, (b)(6) 2017, and it was recommended that he speak with his doctor; no additional medication was prescribed.The customer's blood glucose test result prior to discharge was 200 mg/dl fasting.The customer had tested with the truetrack meter and obtained a result of 215 mg/dl fasting on the morning of (b)(6) 2017.
Event or Problem Description
Consumer reported complaint for e-2 error: sample not detected or using wrong test strip.The e-2 error occurred when the blood sample is absorbed.Customer's diabetes was recently diagnosed.Customer got meter (b)(6) 2017 and has not been able to test his blood sugar.The customer's expected blood glucose test result range was not disclosed.At the time of the call, the customer reported symptoms of dry mouth and urinary frequency.Medical attention was not needed at the time of the call; customer stated he would take his medication.During the call on (b)(6) 2017, a blood test was performed by the customer and produced test result of 452 mg/dl using truetrack meter.Customer had just purchased the test strips - manufacturer's expiration date is 03/27/2020 and open vial date is (b)(6) 2017.Customer was instructed on the proper storage locations.The meter memory was not reviewed for previous test result history.

• 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: 7209346
• Report Number: 1000113657-2018-00083
• Device Sequence Number: 11059085
• Product Code: NBW
• UDI-Device Identifier: 00021292001018
• UDI-Public: (01)00021292001018
• 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): 01/22/2018

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: 03/27/2020
• Device Model Number: TRUETRACK
• Device Catalogue Number: A4H01-81
• Device Lot Number: RU5168
• 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: 12/28/2017
• Initial Report FDA Received Date: 01/22/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1