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); Urinary Frequency / Polyuria (2275); Polydipsia (2604)
Date of Event	01/04/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(manufacturer narrative = t, corrected data = f) (b)(4).Returned meter evaluated with no defect found.Test strips not returned for evaluation.Most likely underlying root cause: mlc-18- user has high glucose value.Note: at call back on (b)(6) 2018, the customer was feeling better and was not currently having any diabetic symptoms.Due to results of hi, customer had sought medical intervention on (b)(6) 2018 and had gone to the hospital that morning.The customer's blood glucose result when tested at hospital was 345 mg/dl; the diagnosis was high blood glucose.Customer was given iv fluids and an insulin shot.Customer stated that numerous tests were run at the hospital; customer was unsure of exactly what tests were performed in addition to blood glucose testing.Customer was advised at the hospital when tested that her a1c was 12.4.Customer left the hospital on (b)(6) 2018.When customer was discharged from the hospital on (b)(6) 2018, customer received a prescription for lantus solostar pen 50 units 1x per day.Additional blood test performed with the truetrack meter produced result of 345 mg/dl.
Event or Problem Description
Consumer reported complaint for hi blood glucose test results.The customer is concerned with test results from results obtained of hi, 523, 587 and 586 mg/dl.The customer's expected fasting blood glucose test result is 150 mg/dl.At the time of the call, the customer reported symptoms of increased urination and increased thirst; customer did not need medical attention at time of call.During the call on (b)(6) 2018, a back to back blood test was not performed by the customer.The product storage was undisclosed.Customer's test strips are expired - the test strip lot manufacturer's expiration date is 07/19/2014 and customer did not know the open vial date.The meter memory was reviewed for previous test result history: (b)(6).Customer is concerned with the results of hi, 523, 587 and 586 mg/dl in the meters memory.

• 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: 7209670
• Report Number: 1000113657-2018-00085
• Device Sequence Number: 11009670
• Product Code: NBW
• UDI-Device Identifier: 00021292001971
• UDI-Public: (01)00021292001971
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 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: 07/19/2014
• Device Model Number: TRUETRACK
• Device Catalogue Number: A4H01-81
• Device Lot Number: RN3979
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/16/2018
• Was the Report Sent to FDA?: No
• Event Location: Home
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/04/2018
• 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
• Outcome Attributed to Adverse Event: Hospitalization