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	Blurred Vision (2137)
Date of Event	05/30/2019
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).Note: manufacturer contacted customer (several attempts) in a follow-up call to ensure that the replacement products resolved the initial concern - unable to establish contact at this time.Product notification letter sent to contact customer care.
Event or Problem Description
Consumer reported complaint for high blood glucose test results.The customer is concerned with test results obtained of 162 and 245 mg/dl.The customer's expected fasting blood glucose test result is 125 mg/dl.Customer also stated that the results from the meter are higher compared to another device; actual meter to meter comparison results were not provided.At the beginning of the call, the customer stated he was having blurry vision; but he did not need medical attention.Customer stated that he drank orange juice, ate something and felt better; customer stated he no longer had blurry vision and was able to continue troubleshooting.Customer was informed to no longer using alcohol wipes and will adjust to washing hands with warm water-soap only and to thoroughly dry hands.The customer declined to perform a back to back blood test during the call.The product is stored according to specification in the living room.The test strip lot manufacturer's expiration date is 07/31/2021 and test strips were opened a week and a half ago.The meter memory was reviewed for previous test result history: (b)(6).

• 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: 8719165
• Report Number: 1000113657-2019-00641
• Device Sequence Number: 19429743
• Product Code: NBW
• UDI-Device Identifier: 00087701405570
• UDI-Public: (01)00087701405570
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 06/20/2019

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: 07/31/2021
• Device Model Number: TRUETRACK
• Device Catalogue Number: A4H01-81
• Device Lot Number: RW5336
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/18/2019
• Was the Report Sent to FDA?: No
• Event Location: Home
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/30/2019
• Initial Report FDA Received Date: 06/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1