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 Code	Hyperglycemia (1905)
Date of Event	05/14/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Product not returned for evaluation.No replacement product needed at this time.Complaint resolved by training during the time of the call.Most likely underlying root cause: mlc-18 user has high glucose value.(b)(4).Note: manufacturer contacted customer on (b)(6) 2017 in a follow-up call in order to ensure the customer's condition since the initial call; she went to urgent care on (b)(6) 2017.She was diagnosed with hyperglycemia (476mg/dl) and was given a shot to bring his blood glucose down.Discharge date undisclosed.
Event or Problem Description
Consumer reported complaint for e-3 and hi blood glucose test results.Daughter is calling on behalf of the customer.The customer is concerned with tests results from results obtained of hi.The customer's expected fasting blood glucose test result range is undisclosed.The customer feels well and did not report any symptoms.Medical attention is not reported as a result of the actual blood glucose results.The product is not stored according to specification in the kitchen.During the call on (b)(6) 2017, a blood test was performed non- fasting by the customer and produced test results of 564mg/dl using true track meter.The test strip lot manufacturer's expiration date is (b)(6)2019 and open vial date is undisclosed.Daughter called in and state that the customer is getting e-3, and after she pulled test strips out of the meter, it reads hi.Explained to customer that an hi may means that the customer's blood sugar is above 600mg/dl.Daughter states that her mother looks fine, has no symptoms of high or low blood sugar and was more concern with the e-3.I troubleshoot for the e-3 and obtained a results of 564mg/dl non- fasting.Listed the possible symptoms of high blood sugar to customer; customer denied having any symptoms of high or low blood sugar.However, customer states she will seek medical attention due to the high results.Was not able to confirm hi results from meter's 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: 6610735
• Report Number: 1000113657-2017-00955
• Device Sequence Number: 14337
• Product Code: NBW
• UDI-Device Identifier: 00087701405570
• UDI-Public: (01)00087701405570
• 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: other
• Initial Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 06/05/2017

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: RU5009
• 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: 05/14/2017
• Initial Report FDA Received Date: 06/05/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1