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	Hyperglycemia (1905); Blurred Vision (2137); Urinary Frequency / Polyuria (2275)
Date of Event	06/20/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Product not yet returned for evaluation.Most likely underlying root cause: mlc-18- user has high glucose value.Test strip udi# (b)(4).Note: manufacturer contacted customer (several attempts) in a follow-up call to ensure that the replacement products resolved the initial concern - unable to establish contact with the customer at this time.Product notification letter sent to customer to contact customer care.
Event or Problem Description
Consumer reported complaint for hi blood glucose test results.Customer also stated she received e-5 error code.At the time of the call on (b)(6) 2018, the customer reported symptoms of dry mouth, increased urination and blurry vision.Customer stated she would seek medical intervention and would go to the hospital.No further information was able to obtained.At follow-up call on (b)(6) 2018, the customer's condition had improved and she did not currently have any diabetic symptoms.Customer stated that after the initial call on (b)(6) 2018, due to the hi and symptoms, she had driven to the er.The customer's lab test blood glucose result when at the hospital was 699 mg/dl.The diagnosis was high blood sugar and customer was given iv and insulin.The customer left the hospital on (b)(6) 2018.No new medications or healthcare program was suggested.Additional blood tests were performed by the customer using the truetrack meter.Information that was unable to be obtained during initial call was obtained during follow-up call on (b)(6) 2018.The meter memory was reviewed for previous test result history and customer was concerned with test result of hi obtained (b)(6) 2018.The customer's expected blood glucose test result range is unknown.During the follow-up call on (b)(6) 2018, a back to back blood test was performed by the customer non-fasting and produced test results of 558 mg/dl and 572 mg/dl using truetrack meter.The product is stored according to specification in the bedroom.The test strip lot manufacturer's expiration date is 07/29/2018 and open vial date is (b)(6) 2018.

• 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: 7690321
• Report Number: 1000113657-2018-00758
• Device Sequence Number: 806146
• Product Code: NBW
• UDI-Device Identifier: 00021292001018
• UDI-Public: (01)00021292001018
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 07/16/2018

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: 07/29/2018
• Device Model Number: TRUETRACK
• Device Catalogue Number: A4H01-81
• Device Lot Number: RT4867
• 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: 06/20/2018
• Initial Report FDA Received Date: 07/16/2018
• 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