MAUDE Adverse Event Report: TRIVIDIA HEALTH, INC. TFOCUS; BLOOD GLUCOSE SYSTEM

Model Number	TFOCUS
Medical Device Problem Codes	Incorrect, Inadequate or Imprecise Result or Readings (1535); High Test Results (2457); Low Test Results (2458)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/28/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(manufacturer narrative = t, corrected data = f) internal report # (b)(4).Product not returned for evaluation.No replacement due to customer going directly to the pharmacy.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 initial concern is resolved - unable to establish contact at this time.Product notification letter sent to contact customer care.
Event or Problem Description
Consumer reported complaint for lo, high and erratic blood glucose test results.The customer is concerned with tests results from results obtained of lo, 112, 165, 167 and 151 mg/dl.Customer was also comparing meter to three other meters.Actual meter to meter comparison results were not provided.Customer stated that he would not eat from the evening to the next morning and would still get results over 120 mg/dl.The customer's expected fasting blood glucose test result range is 80 - 110 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.During the call a back to back blood test was performed by the customer fasting and produced test results of 146 mg/dl and 135 mg/dl using meter.The product is stored according to specification in the bedroom.The test strip lot manufacturer's expiration date is 08/29/2020 and open vial date is 02/2019.The meter memory was reviewed for previous test result history: result 1: lo 845 (b)(6) fasting.Result 2: 112mg/dl (b)(6) 528p fasting.Result 3: 165mg/dl 11:00 (b)(6) fasting.Result 4: 167mg/dl 1058a (b)(6) fasting.Result 5: 151 8:47a (b)(6) fasting.

• Brand Name: TFOCUS
• Common Device Name: BLOOD GLUCOSE SYSTEM
• Manufacturer (Section D): TRIVIDIA HEALTH, INC.; 2400 nw 55th court; fort lauderdale FL 33309
• MDR Report Key: 8540586
• Report Number: 1000113657-2019-00375
• Device Sequence Number: 16580403
• Product Code: NBW
• UDI-Device Identifier: 00021292007744
• UDI-Public: (01)00021292007744
• Combination Product (Y/N): N
• PMA/510(K) Number: K131013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 04/23/2019

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: 08/29/2020
• Device Model Number: TFOCUS
• Device Lot Number: NV1000
• 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: 03/28/2019
• Initial Report FDA Received Date: 04/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1