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 Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/22/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Product not yet returned for evaluation.Most likely underlying root cause: (b)(4)-user had an inaccurate reference: self: the person is using themselves as the reference or how they feel at the time they run the blood test.Test strip udi# (b)(4).
Event or Problem Description
Consumer reported complaint for high blood glucose results.The customer is concerned with results obtained of 250mg/dl.The expected fasting blood glucose test result range is 90 to 120mg/dl.The customer feels well and did not report symptoms.Medical attention is not reported as a result of the actual blood glucose results.The product is stored by customer according to specification in the bedroom.During the call on (b)(6) 2017, a back to back blood test was performed fasting by the customer and produced test results of 188 and 167 mg/dl using true track meter.The test strip lot manufacturer's expiration date is 03/15/2019 and open vial date is (b)(6) 2017.The meter memory was reviewed for previous test result history: (date/time not stored correctly).Result 1 :250mg/dl date: (b)(6) 2017 time:12:10pm fasting.Result 2 :171mg/dl date: (b)(6) 2017 time:12:03pm fasting.Result 3 :199mg/dl date: (b)(6) 2017 time:12:20pm fasting.Result 4 :184mg/dl date: (b)(6) 2017 time:12:21pm fasting.Customer is calling because he states his meter is reading inaccurately.Customer just got the meter today and when he took his first blood test, it read higher than his normal glucose range of 90-120mg/dl fasting.Customer got a reading of 177mg/dl fasting and when he tested 7 minutes later, he got a 250mg/dl and he was concerned so he gave us a call.Customer is not concerned that the readings are different; he is concerned that the results are much higher than his normal range since he has not eaten.

• 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: 7120872
• Report Number: 1000113657-2017-02075
• Device Sequence Number: 11084639
• Product Code: NBW
• UDI-Device Identifier: 00021292001971
• UDI-Public: (01)00021292001971
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 12/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: TRUETRACK
• Device Catalogue Number: A4H01-81
• Device Lot Number: RT4989
• 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: 11/22/2017
• Initial Report FDA Received Date: 12/15/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1