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	06/04/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(manufacturer narrative = t, corrected data = f) internal report # (b)(4) returned meter evaluated with no defect found.Test strips not returned for evaluation.Most likely underlying root cause : mlc-55 user had an inaccurate reference: competitor's meter: the end user is comparing results obtained from trividia's bgm system to the results from a competitor's bgm system.Test strip udi#(b)(4).
Event or Problem Description
Consumer reported complaint for high blood glucose test results.The customer is concerned with tests results from results obtained of 178, 192 and 210 mg/dl.Customer stated she was also comparing the meter to another company's meter (meter to meter comparison results were not provided).The customer's expected fasting blood glucose test result range is 88 - 129 mg/dl.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 test strip lot manufacturer's expiration date is 12/31/2018 and open vial date is may 2017.Customer did not have any test strips left.Code chip matches the test strips.During the call on (b)(6)2017, a back to back blood test was performed by the customer fasting and produced test results of 123 mg/dl and 126 mg/dl using truetrack meter; customer was satisfied with back to back results.Customer had opened a new vial of test strips for the back to back test - lot rt5029.The product is stored according to specification.The meter memory was reviewed for previous test result history (time not set; customer stated she takes her blood tests between 8 and 9 am.): 1:178mg/dl (b)(6) 2017 12:24 pm fasting:yes.2:192mg/dl (b)(6) 2017 11:13 am fasting:yes.3:210mg/dl (b)(6) 2017 10:57 am fasting:yes.4:133mg/dl (b)(6) 2017 03:40 pm fasting:yes.5:129mg/dl (b)(6) 2017 03:37 pm fasting:yes.Memory concerns:the customer is concerned with the result of 178, 192 and 210mg/dl in the 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: 6667737
• Report Number: 1000113657-2017-01091
• Device Sequence Number: 11233465
• Product Code: NBW
• UDI-Device Identifier: 00021292004576
• UDI-Public: (01)00021292004576
• 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): 06/26/2017

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: 12/31/2018
• Device Model Number: TRUETRACK
• Device Catalogue Number: A4H01-81
• Device Lot Number: RT4942
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2017
• Was the Report Sent to FDA?: No
• Event Location: Home
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/04/2017
• Initial Report FDA Received Date: 06/26/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1