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	10/31/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Product not yet returned for evaluation.Most likely underlying root cause: mlc-20-user's test strip had poor storage (kitchen).(b)(4).
Event or Problem Description
Consumer reported complaint for high blood glucose test results.The customer is concerned with test results from results obtained of 172, 182, 223, 153 and 167 mg/dl.The customer's expected fasting blood glucose test result range is 107 - 120 mg/dl.Customer stated the he has been obtaining the high results since he started using the test strips two - three weeks ago.The customer feels well and did not report any symptoms.Customer stated that he had gone to the doctor for his normal visit and told the doctor about the meter.The doctor had done blood work; customer could not remember what the results were but stated that the doctor took him off his high dosage of metformin since his blood work was good.During the call on (b)(6) 2017, a back to back blood test was not performed by the customer.The product is not stored according to specification and is stored in the kitchen.The test strip lot manufacturer's expiration date is 06/21/2019 and open vial date at time of call is two - three weeks.Customer had the correct code chip in the meter.The meter memory was reviewed for previous test result history (time not set): result 1: 172 mg/dl date: (b)(6) 2017time:1:18pm fasting, result 2 :182 mg/dl date: (b)(6) 2017time: 1:49pm fasting, result 3 :223 mg/dl date: (b)(6) 2017time:1:48pm fasting, result 4 :153 mg/dl date:(b)(6) 2017 time: 1:24pm fasting, result 5 :167 mg/dl date:(b)(6) 2017 time: 1:09pm fasting.

• 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: 7048485
• Report Number: 1000113657-2017-01981
• Device Sequence Number: 1186319
• Product Code: NBW
• UDI-Device Identifier: 00021292001797
• UDI-Public: (01)00021292001797
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 11/21/2017

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 Expiration Date: 06/21/2019
• Device Model Number: TRUETRACK
• Device Catalogue Number: A4H01-81
• Device Lot Number: RU5065
• 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: 10/31/2017
• Initial Report FDA Received Date: 11/21/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1